chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes simplex 1 (fever blisters in nose) from both doses of vaccine; Herpes simplex 1 (fever blisters in nose) from both doses of vaccine; 2nd vaccine causes 102-103 fever for 12 hours; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old (non-pregnant) female patient received second dose of bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:45 (at the age of 40-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none, patient did not have known allergies, patient was not allergic to medications, food, or other products. Concomitant medication included Estradiol patch .075 (ESTRADIOL) (Other medications the patient received within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient previously received first does of bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:45 (at the age of 40-year-old) at dose 1, single for covid-19 immunisation, for which patient experienced Herpes simplex 1 (fever blisters in nose) from both doses of vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 09:00 the patient experienced herpes simplex 1 (fever blisters in nose) from both doses of vaccine on and 2nd vaccine causes 102-103 fever for 12 hours. The patient underwent lab tests and procedures which included fever: 102-103 on 01Apr2021 (2nd vaccine causes 102-103 fever for 12 hours). Patient did not receive treatment for the adverse events. Outcome of the events was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I have been puking with cold chills; I have been puking with cold chills; This is a spontaneous report from a contactable consumer (Patient). A 39-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 26May2021 15:15, as a single dose for COVID-19 Immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not re-ported), via an unspecified route of administration, administered in Arm Left on 5May2021 21:00, as a single dose for COVID-19 Immunization. On 27May2021 05:15, the patient experienced puking with cold chills. The patient reported that after getting the second dose, he puked in the middle of the night around 5 am. The patient had not tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of adverse events and the patient did not receive any treatment. The outcome of the events was reported as resolving.  Follow-up (28May2021): New information received from contactable consumer. Clinical course of events updated.  Information about batch/ lot number has been requested.
after vaccine felt dizzy and lightheaded, felt worse like going to pass out, rapid response called and patient sent to emergency dept.
Started off with sore arm. Then redness and warmth. Thur morning 4/23 fever with arm swollen and hot. By evening arm welted down entire upper arm. Fever increased. Fri, Sat Sun continued icing and took ibuprofen every 6 hrs.  By Sun/Mon started to ease up on symptoms. Today continues to be slightly red, slight warmth and improving.
10 days post injection, injection site became swollen & itchy & developed a red rash.
Adverse: (Common adverse effects-Fever, chills, body aches, joint pain) Vaginal bleeding the same night of vaccination 5/3/2021, last menstrual period 4/19/2021, no abdominal pain  or cramps, light to moderate vaginal bleeding with clots Treatment: Medroxyprogesterone 10mg 2 tabs PO BID started on 6/24/2021, Biopsy and PAP smear performed on 7/9/2021, Hysrteroscopy, D & C and possible polypectomy scheduled on 7/26/2021, 2 weeks post-op check up on 8/10/2021, Decidua cast passed on 7/19/2021.
Diarrhea, vomiting, severe aches, fever beginning 12 hours after vaccine and lasting for approximately 24 hours.
LEFT SHOULDER JOINT PAIN ONSET WITHIN ONE DAY AFTER INJECTION. PRESENTATION CONSISTENT WITH Shoulder Injury Related to Vaccine Administration,.  Pain. decreased tolerance for exertion/lifting, persisting for over 40 days.
kind of itchy for four days; arm swelling; arm sore, when she would raise it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (kind of itchy for four days), PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (arm sore, when she would raise it) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination.     Concomitant products included medications for high blood pressure, medications for cholesterol and LEVOTHYROXINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (kind of itchy for four days), PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (arm sore, when she would raise it). At the time of the report, PRURITUS (kind of itchy for four days), PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (arm sore, when she would raise it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO158) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 21:00, the patient experienced temperature of 101.3 (unit unspecified), fever including shakes, chills, vomiting, pain in the injection site, myalgia, inflamed lymph node behind the right ear, headache and fatigue. It was reported that these events lasted for 36 hours however, fatigue and inflamed lymph node behind the right ear were ongoing but the patient was generally healthy. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events temperature of 101.3/ fever, shakes, chills, vomiting, pain in the injection site, myalgia and headache was recovered on 23Apr2021 at 09:00 while outcome of the events inflamed lymph node behind the right ear and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccines given 5/22/12. On 5/24/12 c/o pain, swelling & redness in (RT) arm & seen by school RN. Area on redness on (RT) deltoid 3" in diameter with center darker red area 1" in diameter. C/O H/A, pain in area & (RT) axilla. No fever: temp 98.5. Advised to see MD if area of redness increases, pain increases, or fever 101 degrees or elevates.
2 months old patient was vaccinated with pentacel that was not mixed correctly and DTap-IPV portion was only administered while ActHIB was not given, no AE; Initial information received on 26-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 months old male patient who was vaccinated with 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ261AAA and expiration date: 14-May-2021) that was not mixed correctly and given for prophylactic vaccination on 25-Jun-2020. There was a reconstitution error due to only dtap-ipv portion administered without acthib.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination on an unknown date.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient came in for pfizer booster;  I gave Pfizer booster instead of Pfizer Bivalent booster; we did not have the bivalent vaccine at the time; so I should have told patient to come back when we had vaccine
Sore, swollen right deltoid, generalized achiness, headache, chills, and muscle soreness.
Moderna COVID-19 Vaccine .  Developed axillary lymph nodes enlargement.
lightheaded/dizzy, pale, clammy/hot feeling; 5 minutes after receiving vaccine. Histsory of feeling dizzy after vaccines/blood draws. RPh had patient remain for observation in private area first in supine position, then seated. under direct pharmacist observation 12:40pm-1:11pm. Patient declined EMS services.
Body aches 5 hours after injection.   Fever of 102°f 12 hours after injection.   24 hours later, persistent flu like symptoms, low fever in the 100s.  I had covid in November.
Pt was given PNEUMOVAX at pharmacy on 9/20/17 am and by that evening pt says his arm was swollen and red down to his elbow. Denies fevers. Pt was started on anitibiotic by doctor.
Lacey rash, joint swelling and intense pain all over body, high fever that last months. Bleeding under the eyes.
Headache; all over body ache; muscle cramping; Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose); Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2022 as dose 1, single (Lot number: 012M20A), in left arm, on 27Nov2022 as dose 2, single (Lot number: 032M20A), in right arm, on 27Nov2022 as dose 3 (booster, single (Lot number: 012H21B), in right arm and on 27Nov2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 27Nov2022, outcome "unknown" and all described as "Moderna: 27Nov2022 (1-4 dose); Pfizer Bivalent: 27Nov2022(5th dose)"; HEADACHE (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering"; PAIN (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering", described as "all over body ache"; MUSCLE SPASMS (non-serious) with onset 28Nov2022 at 00:30, outcome "recovering", described as "muscle cramping". Therapeutic measures were not taken as a result of headache, pain, muscle spasms.  Additional information: Age group was reported as elderly (65+ Years).The patient received more than 3 doses.  There were no other vaccine in four weeks. There were no other medications in two weeks. The patient didn't experienced covid prior vaccination. The patient didn't experienced covid tested post vaccination. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious media case received from a non-healthcare professional.  This case is linked to case 2020SA355681 (same reporter).  This case involved an adult patient of an unknown age and gender who experienced flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient took the flu shots and got the flu (influenza).   No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
pt states that after she got the covid vax and within 10 minutes she started getting light headed so she sat down.  After sitting about 10 minutes she felt better but felt like she was having a mild vertigo episode.  After she got home , she ate and laid down where she was having another dizzy spell or vertigo episode and was also nauseated.  She woke up next day, she got up but felt drained so went back to bed.  Through out the night the next night she had chills, nausea, runny nose and bad vertigo episodes.   She woke up w/ diarrhea and more vertigo.  Pt had an appt w/ her physical therapist today 2/25/2021.  They did a procedure to treat her vertigo.  She is still having nauseated, having chills and vertigo episodes at this time.  Pt states she is going to contact her PCP today.
Pt tolerated well. Instructed parent to let pt wait for 15 mins to observe any allergic reactions and RTC for DTaP#4 after trip.
Administration error. Client received Bexsero as first dose of Men B series on 11/23/2022, returned to clinic on 12/29/2022 and received Trumenba as a second dose. No adverse events noted. Upon note of error, guardian was contacted via phone and made aware of situation. Guardian advised to receive one more dose of either product to complete series. Guardian opted to complete Bexsero and will return to clinic in 1 month.
The patient reported having Covid arm, which started about 1 week after her first injection of Moderna.  She said her arm was itchy and swollen, but it resolved after a couple of days.
Cellulitis of right deltoid 3 weeks post injection. This occurred with second dose as well but was not considered a reaction at that time.
4 inch diameter red lump on Right arm. Lump area is itchy and is in area where Anthrax Shot #8 was given.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in unspecified number of patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patients received FLULAVAL QUADRIVALENT. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patients experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that several patients or employees received FLULAVAL and they complained of localized pain, redness and swelling at the injection site. At the time of reporting, the reporter did not have access to the patient identifiers or further product details. The reporter stated that these complaints of adverse events had been a lot more frequent that in the past and the events were occurring with patients or employees who had reported not having these complaints before. No further information was reported regarding the event.
nose bleeds; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age 68; unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 at a single dose for covid-19 immunisation. Medical history included patient has a heart problem and he is on a blood thinner because he has atrial fibrillation, nose bleeds, dizziness and tiredness because of his medical problems. The patient's concomitant medications were not reported. On 03Mar2021, patient received the covid 19 vaccination.  Patient have gotten nose bleeds periodically since the vaccine but he did get nose bleeds anyway because he was on blood thinners. He was just curious if this is a side effect of the vaccine or if it's just his normal nose bleed. The patient feel fine, and had some of the symptoms anyway without the vaccine that are listed in this packet like dizziness and tiredness because of his medical problems. The nurse asked the patient if he was on blood thinner which he was, he had been on blood thinner through 3, 4-5 years, he has atrial-fib (History details) and that night (03Mar2021), he had a nose bleed and then the next day, he had another nose bleed and then on 05Mar2021, he had a couple but they were very small. He was going through the pamphlets they gave him to read about it and everything and none of the side effects mentions, nose bleed or anything like that. So, patient was only calling to see if this one of the side effects because he was on a blood thinner. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Pain, swelling, and rash at injection site (Prevnar 20); aches, tiredness, 101° fever (influenza shot)
Myasthenia gravis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 20-DEC-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination, unsure it's in December 2016 or 2017), the patient suffered from and was diagnosed with transverse myelitis. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of transverse myelitis was considered as not recovered. The lawyer considered it to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be medically significant. Transverse myelitis was considered as disable by reporting lawyer.
1st HPV series done on 3/20/07. First grand mal seizure on 04/16/07; Has been diagnosed epileptic on 5/3/07 6/26/08-records received-seen in ED 4/9/07-C/Ogeneralized shaking, confused after event. Impression new onset of seizure. Seen on 5/11/07-Over past year and half has had events characterized by right foot tingling, sometimes shaking, head turning to right. These spells have increased over past 1-2 months, especially tingling sensation. Seizure event eyes rolled back, jerking and limp. Impression:complex partial seizures with secondary generalization except EEG is showing tendencies towards generalized epilepsy.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4230743-00 (Agency).  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 71 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, cf for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of rheumatoid arthritis flare and covid vaccine caused rheumatoid arthritis flare with humira(adalimumab) was no reasonable possibility.  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 current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event rheumatoid arthritis cannot be 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.
pt recv vax 27OCT97 & that same day pt exp chemical phlebitis;
Myalgia, Fever & NauseaVomiting Narrative: Nausea fever body aches