chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL9267), in right arm, on 23Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FJ8757) for Covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN, start date: 25Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The other medication in 2weeks: Yes. Other medication in 2 weeks were Pregabalin, (other medication in 2weeks brand= Cipla, other medication in 2 weeks start date:25Mar2022). No follow-up attempts are possible. No further information is expected.
pt recv vax 19OCT95 & 30OCT95 pt devel a diffuse rash;MD reported pt was previously vaccinated w/MMR
patient experienced extreme pain at site of injection. she took tyelnol the same evening. was woken up at 1am and had to take additional tylenol. The pain stopped after the second dose. Later the next day she found her arm bruised below the area the vaccine was injected
Sore right shoulder and right armpit about two hours later. Multiple fevers never exceeding 100.5 - fevers on April 3 around 6pm and the on April 4 - around 4pm
on or about 9DEC92 pt became very sick w/sx of repeated vomiting of foods, sl sz, lost 7 lbs, fatigue, pupils rolled back in head & when notified the clinic was told dont worry pt would be OK;
Post vax, the pt developed swollen right arm with some redness. Treated with Benadryl.
Started feeling nauseous and light headed at 8:00 AM 4/15/2021.  Called 911 at 2:00 PM and was transported to Hospital. Diagnosed with complete AV Block and had Accolade L311 MRI DR Pacemaker on 4/16/2021.  Released from hospital on 4/17/2021.
Patient reported feeling dizzy about 10 mins after vaccine administration. She lied down on exam table for about 30 mins and felt better. VS stable. Her spouse came to pick her up.
Patient stated they didn't feel well at all and was sweating.  I told him I should give him an Epi Pen, but he preferred receiving generic Benadryl. At approximately 12:50pm he was given 50mg of diphenhydramine since he wasn't having any swelling to inhibit swallowing. He drank half the bottle of water. He stated his vision was spotty, but getting better. I told him we should give him the epi pen and call 911.  He asked us to call girlfriend to let her know he wasn't feeling well. After another few minutes he stated his vision was getting better and feeling much better. At 1:12 we took his blood pressure 102/67 pulse of 47.  He stated the pressure and pulse were normal for him since he is a runner.  (He had run a marathon the previous weekend). He was monitored for 30 minutes.  After the 30 minutes, he felt fairly normal and was going to be with someone the rest of the day working at home. He was given more benadryl and advised to seek emergency medical attention if symptoms returned and were worse. Around 7;30pm I called to check on him. He had taken another dose of benadryl 50mg.  He still felt comfortable not seeking er attention since he was going to be with friends the rest of the evening and night.
p/vax pt had mild cold & tx w/med;MOC noted that pt had 4 -5 episodes of eyes rollign back, arms flexing, fists clenching & shaking;MD notified;to ER via amb;had 30 to 45second episodeof sz activity w/rt eye deviation;T38.1C;dx sz disorder
Headache, Myalgia, Backache, states the headache was severe and lasted 5 days Narrative:  Other Relevant History:
small reddened area approx 2cm lt arm;swelling, warm to touch, non painful on 10/27/99;10/28/99 pt reports area larger, very red & warm to touch;10/29/99 area cont to be swollen & now very tender;dx cellulitis;rx meds;
Immediately after receiving the vaccination, patient presented to be lightheaded and rested her head on the table.  Upon assessment, patient states that she felt lightheaded, seeing orbs, dilated pupils. Upon arrival from EMS, patient did faint for no longer than 10 seconds and regain consciousness.
This spontaneous report as received from a nurse refers to an 8 months 16 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have  been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Fever began that night.  Fever lasted until approximately 11 a.m. on 12/14/2013.  A visible rash appeared on baby's face that evening and spread to the rest of her body.
Getting ready to get Pfizer Covid 19 Booster Vaccine, because every time got Moderna Vaccine, got sick.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Getting ready to get Pfizer Covid 19 Booster Vaccine, because every time got Moderna Vaccine, got sick.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid stimulating hormone deficiency (did not have a Thyroid). Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid stimulating hormone deficiency.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Getting ready to get Pfizer Covid 19 Booster Vaccine, because every time got Moderna Vaccine, got sick.). At the time of the report, ILLNESS (Getting ready to get Pfizer Covid 19 Booster Vaccine, because every time got Moderna Vaccine, got sick.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: Since Jan-2022, put on about 15 pounds.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Till 24-Oct-2022, the patient had been waiting for Levoxyl 112 micrograms to arrive from backorder since 19-Sep-2022. The patient took 112 microgram dose of Levoxyl. Patient did not had thyroid, dependent on Levoxyl to survive. She used Levoxyl because was sensitive to inconsistencies in dosage in other product. Since 2015 Levoxyl had been on backordered many times, which doctor warned the patient about it. She had taken Levoxyl 125 mcg tablets, nibbling off dose and throwing the rest away. When took Synthroid, levels were up and down. The patient was getting ready to get Pfizer Covid 19 Booster Vaccine, because every time she took Moderna vaccine, she got sick. She she might get Moderna Vaccine again. However, she did not know about it. The point was that could not get Levoxyl medication. She began Levoxyl  7 years back. Started as soon as went on Levoxyl, was warned about difficulty to get Levoxyl. Was just given 5 Levoxyl. She was getting Levoxyl off and on for last 6 weeks. Since Jan-2022, had  put on about 15 pounds, but currently the dosage was 112 micrograms Levoxyl. She had previously taken Levoxyl 125mcg tablets, nibbling off dose and throwing the rest away. As she had not been able to consistently get 112 micrograms of Levoxyl, but had leftover 125 micrograms, nibbles off a little bit and spits out and takes pill to try to get as close as possible to 112 micrograms. She could not get blood tests because would be inconsistent and would not be able to prescribe new dosage, would not be able to estimate.  No treatment information was provided.   Reporter did not allow further contact
Fever, chills, myalgias, fatigue, pain at injection site beginning within 10 hrs of inocculation
Abdominal/ stomach pain (mild to moderate) gas; Headache; Mild chest pain; Extreme weakness and fatigue; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; Upper body muscle weakness and pain, especially in left arm; extreme weakness and fatigue; upper abdominal/stomach pain (mild to moderate).; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and hernia hiatal. The patient had no known allergies. Concomitant medications included cyanocobalamin (oral B-12) (MANUFACTURER UNKNOWN), iron supplement (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unspecified date, unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, on the day of vaccination, the patient experienced upper abdominal/stomach pain (mild to moderate). On 22Apr2021, 2 days after vaccination, the patient experienced headache, mild chest pain, gas, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm. The symptoms were persistent for 3 days at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal/ stomach pain (mild to moderate), gas, headache, mild chest pain, extreme weakness, fatigue, upper body muscle weakness and pain, especially in left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
throat tighness and heas and neck uticarial rash appx 8 hours after injection.   self treated with  pepcid/zantac
Information has been received from a RN concerning a male pt who on 29-MAR-2000 was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) SC. On 09-APR-2000, the pt developed a fever of 105F and was diagnosed with acute febrile illness. The pt was doing better per the RN. The reporter had a concern about the lot of vaccine administered (17333) because of two adverse experiences were reported and the office used 200 doses. Follow up info from a RN indicated that the office have had no other problems other than the two adverse experiences she reported previously . It was reported that the pt recovered.
Ice Cold Extremities - Hands and Feet; Nausea; Vomiting; Fever (101.8F); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)). At the time of the report, PERIPHERAL COLDNESS (Ice Cold Extremities - Hands and Feet), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever (101.8F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Pyrexia: 101.8 (High) 101.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
moderate vaginal bleeding / spotting that occurs overnight; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative. A 59 years old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included 10 years post-menopausal from an unknown date and unknown if ongoing. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN) on 23Mar2021 as dose 1, single for COVID-19 immunisation. On 26Apr2021, the patient woke with moderate vaginal bleeding. Persisted for past 2 weeks bleeding/ spotting that occurs overnight. No clots. Spotting was continued. No previous spotting for past 10 years. The outcome of the events was reported as not recovered.  Case comment: Based on close temporal relationship the causal association between the reported event postmenopausal bleeding and the usage of the vaccine BNT162B2 cannot be excluded. The case will be reassessed if there is any new information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initially just pain in left arm after first shot.  Approximately 2-3 weeks after of receiving the first shot I noticed a lump on my right breast.  My physician sent me for a Mammogram and it turned out to be a benign cyst.  I never had a cyst on my breast ever in my 59 years and I asked the doctor at the time if it had something to do with the shot.  After the second shot, I was ill the next day (fever, severe headache, and body aches).  Approximately a 2 weeks after receiving the second shot I noticed a lump on the middle of my neck by my thyroid.  I went to an endocrinologist who is indicated that I have nodes on my thyroid.  I am still going for testing and I feel that both instances are associated with receiving the vaccine.
Within five minutes of the vaccination, the patient expressed distress.  Patient was slumped over in his seat, extremely labored breathing and his eyes were rolling to the back of his head.  The Pharmacist spoke to the patient to see how he was feeling but he wasn't very responsive so we administered an Epipen and immediaetly called 911.  The paramedics came at around 6:20pm and checked the patients vitals. EMT said the patients vitals were normal and have the patient the option to go to the ER.  Patient was alert and able to drink water.   Patient refused hospitalization.  We advised the patient to go directly to the emergency room if he was developing any symptoms once home and to follow up with his primary care provider.
Guillain-Barré sndrome. IV, IgG, plasmapheresis. Recovering.
I started having a sore throat, the next day I had a runny nose and was achy fever over 100F. The next day I  started feeling worse so I decided to use my home COVID-19 Test and it came back positive. My wife called to get me in to a Urgent Care to try and get the Paxlovid but they said I needed to get the lab work done.
Patient reports having redness at injections site and it has now become hard, almost like a mosquito bite
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. W1B2A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to metals (Allergic to gold.). Concomitant products included FENOFIBRATE, FAMOTIDINE (PEPCID [FAMOTIDINE]), FAMOTIDINE and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.). The patient was treated with FLUOCINONIDE (topical) ongoing since an unknown date for Itching, at an unspecified dose and frequency and MONTELUKAST on 21-Nov-2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.This case was linked to MOD-2021-396111 (Patient Link).
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium
joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approximately nine hours after receiving the vaccination, I had chills and muscle aches that lasted for a few hours. Additionally there is pain at the site of the injection.
Pneumonia; Acute hypercapnic; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 10-FEB-2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). On an unknown date (reported as shortly after receiving the vaccine), the pt suffered dyspnea and wheezing. The pt was admitted to hospital and he was diagnosed with pneumonia and acute hypercapnic respiratory failure on an unknown date. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and severe and permanent personal injuries. The outcome of the events pneumonia and acute hypercapnic respiratory failure was considered as not recovered. The reporter considered pneumonia and acute hypercapnic respiratory failure to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events of pneumonia and acute hypercapnic respiratory failure were determined to be medically significant and disabling
the morning after receiving the vaccine, developed chills, low grade fever and vomiting: progressed to include diarrhea
Began with a red itchy scaly spots on both arms above and below elbows, then smaller spots on legs about 2 weeks after 2nd  COVID-19 vaccine. All spots still there. Has been treating with natural homopathic cream with some help with itching
Patient states she felt a lump under the area that she had the vaccine. She had had this previously with other vaccines. This occurred on 1/17/18 with vaccination. On 3/6/18 she noticed redness and warmth at the injection site overlying the lump.
The pt was seen after hours and mom described a fever of 103.2, high pitched crying and vomiting 4 times.
Pt developed fever and vomiting 1 day after immunization. A red patch appeared over left deltoid area same day. (tx ice packs and Tylenol). No an 8cm reddish pheomorphic papule visible, tender, over deltoid area. No adenopathy.
This is a spontaneous report from a contactable nurse and pharmacist. The nurse reported same events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 3rd of 4 reports. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in left deltoid on 19Jun2015. The patient did not receive other vaccines. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness. The patient called the office and returned for an office visit to see the doctor for the occurred events. The patient was not hospitalized for the event and had no pain or fever so no antibiotic was given. The patient received TYLENOL and ice for the events. The outcome of the events was unknown. Follow-up (23JUL2015): Follow-up attempts completed. No further information expected. Follow-up (10Aug2015): Additional information reported from the contactable pharmacist includes gender and age of the patient, date of vaccination and treatment received. Event Cellulitis added. Case upgraded to serious.
After taking my Jansen booster shot, I developed rashes/ hives all over my body starting from my back and then slowly spreading to my chest, thighs, arms and legs (in that order) as days went by. The initial reaction was within 48 hours of my shot and it has been 9 days since the booster shot and the conditions dont seem to subside.