chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 48 hours excessive sneezing and runny nose lasting 1 day.; After 48 hours excessive sneezing and runny nose lasting 1 day.; After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days.; After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days.; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Nov2021 (Lot number: FH8030) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included MULTIVITAMINS (unspecified). Past drug history included: Macrobid, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203, Anatomical site: left arm), administration date: 19Apr2021, when the patient was 63 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0170, Anatomical site: left arm), administration date: 10May2021, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) both with onset 29Nov2021, outcome "recovered" (03Dec2021), and both described as "After 24 hours swollen and painful lymph nodes in left armpit lasting 5 days"; SNEEZING (non-serious), RHINORRHOEA (non-serious) both with onset 29Nov2021, outcome "recovered" (30Nov2021), and both described as "After 48 hours excessive sneezing and runny nose lasting 1 day". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, sneezing and rhinorrhoea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
anaphylactic reaction; A report was received from a healthcare facility staff member concerning a  50 year old, female patient (a nurse) who was participating in the mRNA-1273 Emergency Use Program and experienced an anaphylactic reaction.  No relevant concomitant medications and medical history were reported.    The patient received their first of two planned doses of mRNA-1273 on 19-DEC-2020.   On 26-JAN-2021, the patient received their second of two planned doses of mRNA-1273 (Batch 030L20A) in her Left deltoid arm (IM injection) and on the same day, experienced the serious adverse event of anaphylactic reaction.  She was transported by ambulance to the ER. She stayed there for one day and now is fine.  Treatment included Benadryl, epinephrine, steroid, advance, peptide, Motrin.   Laboratory details was not provided.  The event, anaphylactic reaction, was considered recovered on 26-JAN-2021.  Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Swelling, erythema, induration of 40-50 mm; 36 hrs later was nauseated, chills, migraine; 48-72 hrs later "didn't feel good" area was hot, red, swollen with induration.  Reaction improved by 4th & 5th day when student returned to the clinic for other tests and asked about her arm. Physician evaluated and advised not to take further TD injections. Allergies include sulfa & Zithromax.
After 2 doses, I continue to get outbreaks/ suspected vaccination failure; I continue to get outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2 doses of Shingrix 2 months apart and continued to get outbreaks of shingles, so took 1000 mg of Valacyclovir every day as suppression therapy. The patient asked if he/she could try third shingles vaccine to see if it works. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided. This case was linked with case US2022AMR041251 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR041251:same reporter
Multiple instances (about 30) of patients receiving incorrect vaccine due to look alike vials between monovalent and bivalent vaccine.
I had a small burning sensation after the initial injection near the injection site. Felt fine for the rest of the morning and afternoon. In the evening I started to feel feverish. It was at 99.5. When I woke up this morning my fever had progressed to 101.8. I do have soreness near the injection site as well.
Within 15 mins of the vaccine I could feel a mild tightening in my chest. By 8 am. the next morning I had a fluttering heart, heart palpitations, and an overall heaviness in my chest. By Monday Nov 29 I started to get sharp pains in my chest (through my heart area). By Tuesday I made a trip to ER at local Hospital for extreme pain in entire chest area (upper back), fluttering heart, heart palpitations, difficulty breathing, and pains through heart. They tested me and sent me home saying I should monitor it and come back if it worsened, It was just a reaction to the vaccine. A few days later I made another trip to ER with worsening symptoms. I couldn't lie flat on my back because of the pain. The ER diagnosed me with COSTOCHONDRITIS, They said it was a reaction to the vaccine. However, 9 weeks later (most of the symptoms have subsided), BUT I am still bothered by sharp pains in my chest, swollen lymph nodes under arms and in breasts, shortness of breath, etc..
screamed x 3hrs-unable to console;red faced-feel asleep p/3hrs of screaming;APAP 9AM & 1PM;inc temp felt warm per mom;wouldn't nurse
chicken pox lesions -> vesicles with surrounding erythema present diffusely on trunk (anteriorly + posteriorly), groin and upper extremities
big oval area that is a lighter red to his elbow; larger kind of rash area on his injections arm down to his elbow; on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot; fever; sneezing; This spontaneous case was reported by a dentist and describes the occurrence of ERYTHEMA (big oval area that is a lighter red to his elbow), SNEEZING (sneezing), RASH (larger kind of rash area on his injections arm down to his elbow), VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced SNEEZING (sneezing) and PYREXIA (fever). On 31-Oct-2021, the patient experienced ERYTHEMA (big oval area that is a lighter red to his elbow), RASH (larger kind of rash area on his injections arm down to his elbow) and VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot). On 01-Nov-2021, SNEEZING (sneezing) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (big oval area that is a lighter red to his elbow), RASH (larger kind of rash area on his injections arm down to his elbow) and VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Patient given 2nd Moderna dose after use-by date of 02/10/2022.
One week after vaccine went for first run since vaccine. Later that evening injection site itching, red, with hives beginning. Increased in severity that night and remained for a couple of days, affected area measuring 4" x 3". Unsure if running was a factor but only correlating event. If relevant - run was 30minutes with HR in peak-zone for 19min and cardio-zone for 8min - max HR during run 188. If relevant - did not have this reaction immediately after vaccination - had only experienced mild-moderate soreness and mild redness at site for 1-3 days.
Pt received second dose of vaccine on 3/29/20 and began to notice swelling and inflammation following day and reported to ER. Adverse effect consistent frist dose reaction. MD at ER administered IV antibiotic and pt was discharged. Pt says she is feeling better and monitoring site.
allergic reaction; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2022 11:30 (Lot number: 330258D) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfa drugs" (unspecified if ongoing); "Nickel" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 330258D, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 13Jan2022, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 09Feb2022 14:00, outcome "recovering", described as "allergic reaction"; PAIN (non-serious), BURNING SENSATION (non-serious), RASH MACULAR (non-serious) all with onset 09Feb2022 14:00, outcome "recovering" and all described as "Raised painful , burny , sore blotches in several places after my 2nd vaccine.". The events "allergic reaction", "raised painful , burny , sore blotches in several places after my 2nd vaccine.", "raised painful , burny , sore blotches in several places after my 2nd vaccine." and "raised painful , burny , sore blotches in several places after my 2nd vaccine." were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity, pain, burning sensation, rash macular.  Additional information: Raised painful, burny, sore blotches in several places after my 2nd vaccine. Went to urgent care clinic and was prescribed meds for an allergic reaction, steroids and hydroxyzine. No other vaccine in four weeks. Patient received Other Medication in two weeks: Multivitamin/ birth control. Patient did not have covid prior vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 1/28/2021 SEPSIS WO ACUTE ORGAN FAILURE, W BACTERIAL SEPTICEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/16/2021 SEPSIS WO ACUTE ORGAN FAILURE, W BACTERIAL SEPTICEMIA R09.02 HYPOXIA 1/23/2021 SEPSIS WO ACUTE ORGAN FAILURE, W BACTERIAL SEPTICEMIA J96.00 ACUTE RESPIRATORY FAILURE 1/28/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/16/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 1/23/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 1/28/2021 MULTIPLE MYELOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/16/2021 MULTIPLE MYELOMA R09.02 HYPOXIA 1/23/2021 MULTIPLE MYELOMA
No additional AE/PQC reported; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-JAN-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # U007860, expiration date 14-JAN-2022 (exact dose and dose number were not provided) for prophylaxis.
little achy; little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little achy) and HEADACHE (little headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (little achy) and HEADACHE (little headache). At the time of the report, MYALGIA (little achy) and HEADACHE (little headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-220441 (Patient Link).
12/26/2021-ER with complaint of back pain/Sciatica and difficulty ambulating. Afebrile. Covid + test on admission. CT head w/o contrast-No acute intracranial Hemorrhage, CT cervical spine wo contrast-No definite acute cervical spinal fracture, CT thoracic spine w/o contrast-No definite acute fracture.  12/26/2021-O2 sat 88%, O2 2L via NC Increased to 98%. Chest x ray- No acute Pulmonary disease. 12/28/2021- AM-Rapid called, hypoxic o2 sat 70% on 4L NC,  NRB applied o2 sat increased 90%. Weaned back to NC 5L. Start remdesivir, heparin and Decadron. Chest x ray-perihilar intersitial bibasilar alveolar opacities. Made palliative. 1/7/2022- Continue on comfort measure, vitals WNL.  1/10/2022-- Increased pain,
Severe joint pain from head to toe, severe muscle aches, profound shivering, headache and injection site swelling, warmth and tenderness all the way into Scilla and up into neck.
No adverse effects noticed by patient. Received the HD flu vaccine even though he isn't 65 for another 6 months.
This spontaneous report was received from a consumer concerning her approximately 17 year old daughter. On an unknown date in June 2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and was told by her doctor that it was ok for the second dose to be given this August 2013 and to return 4 months after second dose for the final (third) dose. No concomitant therapy was reported. Additional information has been requested.
Information has been received from a registered nurse referring to a 11 year old patient of unknown gender. No concurrent condition and medical history was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# J010668, expiry date: 29-APR-2016, intramuscularly in the right arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Left shoulder burned; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced THERMAL BURN (Left shoulder burned) and HEADACHE (Headache). At the time of the report, THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided. No concomitant medication was provided   This case was linked to MOD-2021-338314, MOD-2021-338407 (Patient Link).
Patient stated that after she recieved the PNEUMOVAX 23 on 10/06/18 at 2:40pm, she noticed that her left arm started to swell, redness, very itchy, but no reports of pain or feeling lightheadedness/ dizziness. Pt noticed this event at night sometime and told her daughter about it. Pt came into pharmacy the next day at 1:10pm and informed and showed me (pharmacist) this adverse event. Pt was given to use BENADRYL cream OTC to help with the itching and will inform her Oncologist as well. I informed pt that I will follow up with her in a couple of days to ensure she is doing okay as well inform her MD.
had given an expired acthib vaccine to a patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that had given an expired acthib vaccine (HIB (PRP/T) VACCINE) to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received a dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunization .  On 13-SEP-2022 an expired acthib vaccine to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had given an expired acthib vaccine to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event     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 the guidelines. 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.
Information was received from a pharmacist via Pfizer (other company number 2016 487382) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date within three years, the patient was vaccinated with ZOSTAVAX (dose, lot# and route unknown) for the first time. The patient got shingles on an unspecified date, so the pharmacist gave her the ZOSTAVAX (dose, lot # and route unspecified) second time without realizing in August 2016. The pharmacist confirmed that the patient received ZOSTAVAX twice within three years time span and that was supposed to be a one time vaccination. On 03-OCT-2016, just a couple of weeks ago, the patient got shingles but with not medical diagnosis. The outcome of shingles was unknown. The relationship between the event shingles and ZOSTAVAX was not provided. Additional information is not expected as there was no medical information request.
Approximately 18 -20 hours after both vaccines: Joint pain with stiffness of both shoulders, hips, back. Fatigue. Brain fog. All for 48 hours. By 3rd day post vaccine completely symptom free and feeling very well.  Approximately 18 hours after 2nd vaccine: Fever 101.2-103.1 for 72 hours. All the symptoms reported above, but much worse,  plus marked left elbow pain.  As of this date left elbow pain and stiffness continues to bother me.
Stiff neck and pain in neck and part way up back of head, could not get relief from pain from midnight till about 5 the next morning took ibuprofen and was finally able to sleep awhile.   On day three now and pain and stiffness is better but still has some pain and stiffness and feel tired.
Swollen, red and painful joints.  Swelling and redness has gone away, pain as spread and is not getting better
2 1/2 x 1 1/2 cm non tender nodule under skin of left ant thigh began same day. No fever; getting smaller.
This case was reported by a physician and described the occurrence of Lyme disease symptoms in a 52 year old male pt who received Lyme disease vaccine recombinant (Lymerix). On an unspecified date in 2002, the pt received the second dose of Lymerix. Approx two years after the admin of the second dose of Lymerix, on 06Aug04, the pt was seen by the reporting physician. The reporting physician stated that, the pt presented with Lyme disease symptoms. The reporting physician also stated the following lab results, Igm ELISA test was positive and the western blot was negative. The event was ongoing at the time of initial reporting.
Myalgia, NauseaVomiting, Pain/Discomfort at injection site, fatigue Narrative:
Swollen upper lip; Headache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen upper lip) and HEADACHE (Headache for a few days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache for a few days). On 02-Apr-2021, the patient experienced LIP SWELLING (Swollen upper lip). At the time of the report, LIP SWELLING (Swollen upper lip) and HEADACHE (Headache for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       02Apr2021 the patient had swollen upper lip and she went to Urgent care where she was given Steroid shot. The patient is scared to receive the second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: TCR form is attached email id of the reporter updated.