chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's; products experienced an excursion of ( 4C) for 20 minutes on 9/7 during transport and ( 4C) for 20 minutes on 9/9 during transport.; This spontaneous report as received from a registered nurse refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.      The varicella virus vaccine live (oka/merck)(VARIVAX) vaccine experienced an excursion of ( 4°C) for 20 minutes on 07-SEP-2021 during transport and ( 4°C) for 20 minutes on 09-SEP-2021 during transport.  On 13-SEP-2021, the patient was vaccinated with an inappropriate storage dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U002394 and expiration date 22-JAN-2023, dose reported as 1 (units not provided) (strength and route were not reported) for prophylaxis. The temperature and Time frame was reported as  -10°C to 8°C ( 4°C) for 20 minutes. There was a previous temperature excursion, which was -10°C to 8°C ( 4°C) for 7 hours and 30 minutes. No additional events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005618: US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639: US-009507513-2109USA005641: US-009507513-2109USA005648: US-009507513-2109USA005651: US-009507513-2109USA005662: US-009507513-2109USA005730: US-009507513-2109USA005795: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005628:
having a hard time hearing me; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "having a hard time hearing me". Additional information: Caller mentioned that he already set an appointment in (Pharmacy name withheld), 6pm today. Caller said that he cannot finalize his reservation because they sent him to the multi-page fact sheet. Created manual AE form because the caller mentioned that he was having a hard time hearing and the caller took the Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 3 hours after receiving vaccine, patient experienced redness, warm to touch ,rash, approximately 5 inches around the site of vaccine.
Had the booster done at a local pharmacy on Friday evening at 5 p.m.  Experienced the 'normal' affects of the shot on Saturday. Sunday morning the pain was more excruciating, the area is hot and it is a huge red, itchy, irritating welt. Swelling is most of area between my shoulder and elbow. Very uncomfortable feeling. Today, Tuesday, Feb. 22nd, my arm is no better. I went back to the pharmacy and let them know what happened and to seek possible treatment on my situation. Instead of the guy laughing at me when I let him see my arm and made him aware it was the Pfizer Booster I received, he should have had the proper knowledge to guide me in right direction of treatment. Instead, he gave me this website and told me to tell my story.
One week after the shot the injection site has become swollen , red, and itchy. It is also warm.
pt recv vax & exp fever which may have been as high as 104 to 105 & which lasted for more than 24hr;pt also exp infrequent rash;
Swelling, hives, itching, Rt arm to elbow hot to touch, red local RXN.
Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female (WAES 01042680) who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast). No further details were provided. Additional information has been requested.
At around 3 am. I woke due to excessive sweating and coughing. I also experienced a stuffy nose as well as feeling as though my saliva was thick. I drank water in an attempt to aid the coughing and the water also seemed 'thick'.   I sweat throughout the remainder of the night; in addition to severe left arm pain.
local reaction to the site, slight redness. Next day had a large bout of dizziness, neck fullness and ear fullness with head pressure
Information has been received from a pharmacist concerning a 75 year old patient who on 29-DEC-2008 was vaccinated with VARIVAX (Oka/Merck) (lot # not provided) instead of with ZOSTAVAX (Oka/Merck) (not reported to be product confusion).  No adverse effect noted.  Patient sought unspecified medical attention.  Further information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 74-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing) and high cholesterol (unspecified if ongoing). Concomitant medications not reported. The patient experienced influenza-like illness (flu-like symptoms for 2 days post vaccination), with outcome of recovered. No therapeutic measures taken as a result of influenza-like illness. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), AMLODIPINE, LEVOTHYROXINE, MIRTAZAPINE, MONTELUKAST, DRONEDARONE, ROSUVASTATIN, FUROSEMIDE, VALSARTAN and PARICALCITOL for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 HEADACHE (severe headache). The patient was treated with RIMEGEPANT at an unspecified dose and frequency; MOXIFLOXACIN at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency and PROPRANOLOL at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The PCP gave the patient 2 medicines, they didn't help (Nurtec ODT (rimegepant) and Moxifloxacin). The neurologist gave her 2 medicines, methylprednisolone and propranolol, the latter she was still taking, but she felt the same.
Myalgia, Arthralgia, FATIGUE, CHILLS, CONGESTION, INJECTION SITE PAIN Narrative:  Other Relevant History:
Tingling in hands and feet - severe pain throughout body.  Treatment was 5 days of IV IgG administration.
Within 24 hours of injection patient experienced body aches, local vaccine site pain and "vivid dreams' That disturbed sleep. She also had a very sore throat - these symptoms persisted for 5 days and she came in to be seen 11/14/17 - her strep test was negative. I viral illness combined with post-vaccine discomfort was suspected. Patient returned 11/30/17 with a rash consistent with pityriasis rosea, and again with the sore throat - she had been feeling weak tired and achey since 11/10/17. I told the mother I would submit a VAERS form however I personally felt the events all signified a viral illness.
no adverse reaction to vaccination. Patient received extraneous dose of flu vaccine on 01/27/2023, had already been vaccinated on 10/31/2022. Patient received unnecessary dose of Menveo vaccine on 01/27/2023, patient had previously received first and second dose of Menveo on 08/20/2015 and 03/30/2021.
Breathing problems, shortness of breath, hospitalization.  Fatigue, inflamation,  damaged vocal chord
Started period early after second shot.; Having cramps for the first time and they are very painful.; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 14Jun2021 at 07:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fluticasone propionate (FLONASE) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 24May2021 at 08:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. On 16Jun2021, the patient started period early after second shot. She was having cramps for the first time and they are very painful. The patient also had diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 started period early after second shot; she was having cramps for the first time and they are very painful and diarrhea was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 09-NOV-2015 the patient was vaccinated with VARIVAX (Merck) lot # J013903/ exp 30-OCT-2015, subcutaneous (concentration and dosage were not reported). No concurrent therapies were reported. The patient was administered with expired VARIVAX. The VARIVAX (Merck) did not have any previous temperature excursions and was found to be supported with in-house post expiry data. The reporter also stated that the patient experienced no adverse symptoms. No treatment or no laboratory diagnostic studies were reported. Additional information has been requested.
3/18 - received Moderna #1 (not sure where this was done) 3/19 - developed raised itchy rash, mostly on trunk; went to hospital, got prednisone 60, Benadryl, Pepcid, sent home 3/20 - took prednisone 60 and Benadryl at home 3/21 - hives worsened, now involving buttocks, thighs, face, with mild periorbital swelling; went to emergency department, got Benadryl, Pepcid, sent home 3/22 - developed mild lip swelling, admitted to hospital for observation. Got epi 0.3 mg IM, Decadron 10 mg IV, Zyrtec 10 mg, Pepcid 40 mg po, Benadryl 25 mg po, with improvement.  Allergy consulted, felt this was likely delayed hypersensitivity reaction to Moderna, but couldn't exclude lisinopril side effect.  They recommended Zyrtec 10 mg bid for 1 wk, and stay off lisinopril.  Will follow up in Clinic to determine how to approach 2nd shot.
Test COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Test COVID positive) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes mellitus (Diabetes type 2 reported.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Test COVID positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Test COVID positive) had not resolved.        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 concomitant medications were provided. No treatments were reported   This case was linked to MOD21-042702 (E2B Linked Report).; Sender's Comments:  MOD21-042702:Crosslinked MOD-2021-032080
Pt got infection at injection site. Red, warm to touch & hard. Pt put on antibiotic.
Fever - low grade during day (about 98-100 degrees F PO); high at night (102 degrees F PO) 10/12 & 10/13/2011. Itching, redness & swelling - mother reports area about size of tennis ball cut in half began 10/12/2011 and was resolved by 10/14/11. Pale, lethargic & nighttime sweating 10/12 - 10/13/11. No GI or respiratory symptoms. Treatment - ibuprofen and ice applied to arm. Attended school throughout event.
Pt arrived to Clinic at 1329 for 1st dose Novavax. Post vaccine pt reported feeling increased heartrate and feeling anxious. Pt was assessed and monitored by licensed nurse. Vitals HR 88, BP 161/117, O2 98%, RR 18, Temp 98.1. Pt reports having hx of hypertension and baseline is in the high 140s. Pt education performed on side effects/adverse reactions. After being monitored for an additional 20 minutes pt stated she felt good with no existing symptoms. Reassessment vitals: HR 80, O2 98%, BP, 155/107, RR 16, Temp 97.7. Pt left facility stable with no further questions.
gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.
pt woke up @ 530Pm w/t103.1 R; mom took pt to ER-24 hrs observation on peds discharged home; chem  profile all WNL; WBC 26,000;
Patient came to clinic stating arm was very itchy and red. Arm was indeed red, warm, and hard to the touch. Patient stated itchyness began the day after receiving the vaccine, and today (two days later) it was extremely itchy. Patient was told to monitor the site, take Tylenol/Motrin for the discomfort and to use Hydrocortisone cream on arm to help with itchyness. Pharmacy provided all medications to patient.
Intermittent substernal chest pain, daily, started 1 week after receiving vaccine.  Otherwise asymptomatic.
The injection site began to hurt the evening of the day of the injection.  I did not sleep well that night and was generally achy and fatigued the next day.  Additionally I had a very dry mouth .  By that evening I began to feel better although I was still a little tired but by the next day began to feel normal.  The injection site is still tender (day 3) but getting better.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (Lot # L033690 with expiration 14-JUN-2018; lot # L030865 with expiration 07-JUN-2018; lot # L012838 with expiration 10-MAR-2018; lot # L004740 with expiration 16-NOV-2017, dose and route were not reported) (incorrect product storage). The vaccines were exposed to two excursions: 9.8 centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Per Mom's report - patient had a rash on her face that appeared the day after she received the vaccine. She was seen at facility and was given Prednisone, CEPHALEXIN and Hydroxyzine.
An itchy rash appeared on torso the next afternoon, about 24 hours. after receiving the vaccine the previous day. She was already taking prednisone (for unrelated condition) and I advised her to take some BENADRYL on top of that as well.
At about 5am the morning after, got up and got dizzy enough to faint. For about 15 min.. lost complete body functions.  Could not move my own body and had uncontrollable bowel movement.  After getting help back to bed, was very disoriented for awhile until able to sleep.  Still very tired today with sore arm but getting back to normal.
A 16-year old patient was inadvertently administered dose 1 of MODERNA vaccine by volunteer vaccinator. Patient had no immediate adverse reaction, incident was discussed with Mom, counseled on monitoring, management and next doses to be scheduled .
Second dose to be given more than 42 days from first dose; Tested positive for Covid after getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST (Tested positive for Covid after getting first dose) and INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST (Tested positive for Covid after getting first dose). On 18-Sep-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose). On 18-Sep-2021, INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) outcome was unknown. At the time of the report, SARS-COV-2 TEST (Tested positive for Covid after getting first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   The pharmacist reported that the patient who got the first shot on 28-Mar-2021 but was not able to get the second dose because the patient tested positive for Covid.  Concomitant medications were not reported. No treatment information provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history who experienced the unexpected event of SARS-CoV-2 test: positive and incomplete course of vaccination. The event SARS-CoV-2 test: positive occurred approximately 1 day after the first dose of mRNA-1273 and 5 months and 22 days after the first dose of mRNA-1273. The benefit-risk relationship of Spikevax in not affected by this report. This case has been designated as invalid due to missing identifiers.
Information has been received from a registered nurse concerning an 18 year old female, with no pertinent medical history with allergies to erythromycin and sulfamethoxazole (+) SEPTRA who on 06-FEB-2007 was vaccinated with Gardasil (yeast), (Lot # 654885/1424F). There was no concomitant medication. On 06-FEB-2007 the patient developed chest pain when taking deep breaths. No other symptoms. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Inappropriate schedule of vaccine administered; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Colitis.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In August 2021, the patient experienced CHILLS (Chills). On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and CHILLS (Chills) had not resolved.            No concomitant medication was reported. In August 2021, the patient experienced CHILLS. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CHILLS was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Cellulitis from elbow to shoulder area of left arm  Itchy rash covering stomach, sides, hips, neck and chest
The night of July 1, the pain started and fever with chills. During the night the fever broke and I woke up with a rash all over my torso and thighs. The second night I had fever and chills again and the next day the rash started to itch. The rash stayed for several days.
Pt was given Adacel instead of Tdap despite fact Tdap was ordered - no adverse events occurred.