chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore upper right arm; This is a spontaneous report from a contactable Nurse.  A 49-year-old female nurse reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), intramuscular into the left arm ,at single dose for COVID-19 immunization on 21Dec2020 at 11:45 AM in the Workplace clinic. The patient received other medications in two weeks and did not receive other vaccine in four weeks. The patient had known allergies to  medications, food, or other products. Medical history included migraines, depression. On 21Dec2020 starting at 07:00 PM the patient experienced sore upper right arm. Treatment was not received. The outcome of the event was recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number has been requested.
Lyme disease; She was bit by a tick; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Lyme disease) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant) and ARTHROPOD BITE (She was bit by a tick). At the time of the report, LYME DISEASE (Lyme disease) and ARTHROPOD BITE (She was bit by a tick) outcome was unknown.            Treatment included Doxycycline 200 mg.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report obtained from a contactable consumer who reported for her mother in law. A 76-year-old female patient received, on an unspecified date in 2014, PREVNAR13, 0.5 ml single dose. Relevant medical history included pacemaker insertion (cardiac). Concomitant medications were unknown. After the vaccination, the patient said her arm was extremely tendered for several days and she kept asking if she had a black and blue mark or not. She also had flu-like symptoms for 3 days after receiving the shot. She was not bad enough to be stuck in bed. Events recovered on an unknown date. She said she had the same reactions (pain in arm and flu-like symptoms) with influenza vaccine shot in October. Follow-up (13JAN2015, 13JAN2015, and 13JAN2015): New information received from   the same contactable consumer who reported for her mother in law includes: reporter, patient and event details. Follow-up (11MAR2015): Follow-up attempts completed. No further information expected.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had previously experienced dizziness after 1st dose of Moderna. Was given benadryl 25mg 30 minutes prior to vaccine, but patient still experienced mild dizziness. Patient was monitored for 30 minutes with no further reaction.
Information has been received from a pharmacist as part of a marketing research program, refers to an 84 year old female patient. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD) or asthma. In June 2015 the patient was vaccinated with ZOSTAVAX (subcutaneous, strength, lot# and dose were unknown). Concomitant therapies included SPIRIVA. In June 2015 the patient got shingles and the reporter indicated the vaccine was lack of efficacy. The outcome of the events was reported as recovered/resolved in 2015. The reporter considered the events to be non-serious and not related to ZOSTAVAX. Additional information is not expected as the reporter refused to be contact.
Allergic reaction with itching on the body for two days.; Allergic reaction with itching on the body for two days.; But at the moment I have a big red spot with crusting on the edge; But at the moment I have a big red spot with crusting on the edge; and it keeps getting bigger; has a different texture, rough, red and not itchy.; has a different texture, rough, red and not itchy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2022 11:00 (Lot number: FK9729) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0175, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 28Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 07Apr2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "Allergic reaction with itching on the body for two days."; ERYTHEMA (non-serious), SCAB (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "But at the moment I have a big red spot with crusting on the edge"; CONDITION AGGRAVATED (non-serious) with onset 05Feb2022 22:00, outcome "not recovered", described as "and it keeps getting bigger"; DRY SKIN (non-serious), ERYTHEMA (non-serious) all with onset 05Feb2022 22:00, outcome "not recovered" and all described as "has a different texture, rough, red and not itchy.". Therapeutic measures were not taken as a result of hypersensitivity, pruritus, erythema, scab, condition aggravated, dry skin, erythema.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a Nurse referring to unspecified number of patients with unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The Nurse reported that, on 21-SEP-2018 and 29-SEP-2018 multiple unspecified patients administered with improperly stored ROTATEQ lot#N013886, expiry date: 09-DEC-2018. Temperature excursion was in between 9 degrees C to 25 degrees C for 16 minutes. Digital data logger was involved and no previous temperature excursion was reported. No adverse events reported. As of 30-JAN-2019, all telephone attempts to obtain followup information have been unsuccessful.
soreness at injection site; tiredness; didn't feel good; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR151464).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, tiredness and feeling unwell. The patient was treated with ibuprofen. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain, tiredness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 2nd dose, 4 months after 1st dose. The patient experienced soreness at injection site, tiredness and did not feeling good. The patient was treated  with ibuprofen. The patient was feeling good now, soreness was gone. The patient stated that he/she received 2 shingles shot and praying he/she would never get a shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151464:same reporter same patient
Approximately 6 hours after receiving the vaccine in my left arm, I began to experience fatigue, and pain at the injection site. Both symptoms increased in severity for the next few hours, and then I began to experience stiffness in my neck, chills and fever. I took my temperature and it was 99.6 degrees F. I wrapped up in as many blankets as I could and went to sleep, but I couldn't really sleep. I woke up around 9am with the worst headache I've had in recent memory, still feeling feverish. I took 2 ibuprofen and went back to sleep.  I woke up covered in sweat, with no longer any fever or headache. Still some neck stiffness and fatigue, and pain at the injection site.  As of the time of this writing, I am approximately 50 hours out from having had the vaccine. I have not had another fever or headache, and the fatigue is gone, but pain at the injection site and some neck stiffness still persists.
DEATH Narrative:  Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21
About 2 weeks after my second shot, my blood pressure spiked really high (160's to 170's / 90's to 100's), heart palpitations, headaches, dizziness and lightheadedness, nausea sometimes with the lightheadedness, and on several occasions long runs of heart rhythm problems lasting as long as 10 to 12 minutes feeling like I was having a heart attack (hard to breath, coughing, only able to sit down, feeling like my heart was trying to jump out of my chest, neck pain, slight nausea). In the several times this happened, it would abruptly stop and I would quickly feel better. Blood pressure was hard to control. Increasing losartan dose didn't help blood pressure not did trying other meds prescribed by my doctor. Over about 2.5 months the symptoms gradually subsided.
Fever 101.5, shaking, developed cutaneous Leukocytoclastic Vasculitis (feet, legs, abdomen, upper arms). Hands and feet all became swollen.
Information has been received from Merck pregnancy registry through a physician concerning a female who on approximately 15-JAN-2008 was vaccinated IM with the first dose of Gardasil. On approximately 15-JAN-2008 the patient experienced nausea, vomiting, lower abdominal pain and diarrhea. The patient received the second dose at an unspecified date while pregnant. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date refrigerated on 20-Apr-2021.
Pt recv vax on 8/18/98; one hour later pt exp nausea; a body rash in 3 hrs; urticaria in 1 hr.
diagnosed with Graves; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (14Feb2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 12Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Oct2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: BASEDOW'S DISEASE (hospitalization, medically significant) with onset 21Dec2022, outcome "not recovered", described as "diagnosed with Graves". The event "diagnosed with graves" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of basedow's disease.  Clinical course: Patient received her vaccines; 3 total. She had just been diagnosed with Graves and her research says it may be from the vaccine. No, medical inquiry was not forwarded. The reported issue occur after use of a Pfizer product. She had many symptoms. Finally diagnoses with Graves on 21Dec2022 by endocrinologist. Date started (or best estimated period): Oct2022. Admission to hospital due to the event (Does not include emergency room visit without further admission): Yes. She was still experiencing the event. They sent her to primary Dr, who sent her to endocrinologist. No surgical treatment needed for the event. On Dec2022 Propranlol and Methimazole 10 mg 2x's day 10 mg (ongoing) were given as treatment drugs. No other product(s) that were taken together with those indicated above. Patient was always healthy. Covid 19 vaccines taken: 22Jan2021, 12Feb2021, 23Oct2021 and 13Sep2022-Felt bad, then got worse. Symptoms got worse. Finally diagnoses.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
lt school wednesday-noon w/chills, nausea, h/a-mom took temp @ 4PM-102;cont w/h/a through Saturday;RN school nurse states pt is fine today;mom made phone call to MD said poss rxn to hep b;
she's having an allergy now; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer (patient) reported that, a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number and expiry date were unknown) via an unspecified route of administration on 17Mar2021 as a dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously had event (unspecified) when took Zyrtec 10 mg [cetirizine hydrochloride] for an unknown indication. The patient reported that, on an unspecified date she's having an allergy now. Patient asked if she could take again Zyrtec 10 mg which previously, she was taking daily before she had her first dose of the vaccine last 17Mar2021. She stopped taking Zyrtec 10 mg when she had the first dose of the vaccine and she wanted to take it again since she's having an allergy now. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began.  During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol.  On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.
PURPURIC RASH, URTICARIA, SWELLING OF ANKLES, FEET AND HANDS PATIENT REFERRED TO CCMC INFECTIOUS DISEASE, CARDIOLOGY AND RHEUMATOLOGY IF NEEDED
Extreme arm pain for 36 hours following first dose. Unable to sleep or function properly. Pain then subsided for 4 days On day 8, extreme arm pain came back again. Unable to sleep or function properly.
Within 4 hours after administration patient had vomiting, diarrhea, intractable abdominal pain for 48 hours.
Within 10 mins of getting my first injection, i had a terrible headache and felt brain fogginess. That went away about three hours later. My arm then become sore which worsened over a 48 hr period. Tylenol (500mg) didn?t help at all. 48hrs after injection, my arm was red and swollen around injection site. It still is red and swollen 9 days later. Injection site became itchy after 5 days and still is despite taking cetrezine allergy medication.  Four days after injection, i had a mild fever. I was 27 weeks pregnant when i got the injection.
Patient (9 month old) received influenza vaccination; Chicken pox; High fevers; Walking pneumonia; Information has been downloaded from Agency (US-CHIRONMA-PHHY2013US116848).  This spontaneous report was received from an other health professional referring to a 9 months old female patient. The patient's concurrent condition and medical history were not reported. The patient's concomitant therapy included acetaminophen (TYLENOL).  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacture unknown) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization. On 27-DEC-2012, the patient was vaccinated with influenza virus vaccine (unspecified) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization (product administered to patient of inappropriate age). On the same date, the patient was vaccinated with polio vaccine (unspecified) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization.  On 29-DEC-2012, the patient experienced chicken pox, high fevers and walking pneumonia. The outcome of the events chicken pox, high fevers and walking pneumonia was not recovered. The reporter considered the causality assessments between the events chicken pox, high fevers, walking pneumonia and influenza virus vaccine (unspecified) were suspected related. The causality assessments between the events chicken pox, high fevers, walking pneumonia and polio vaccine (unspecified) and varicella virus vaccine live (oka/merck) (manufacture unknown) were unknown.  The reporter considered all the events to be medically significant.
INJECTION SITE: REDNESS, BRUISING, PAIN, KNOT Narrative: EMPLOYEES STATES DEVELOPED JOINT PAIN IN ARM AND HAND OF INJECTION AND NEXT DAY PAIN IN UNDERARM AND SWOLLEN UNDERARM LYMPH NODES ON INJECTION SIDE.
Narrative: COVID infection following COVID vaccine series 02/02, Moderna, dose #1 03/03, Moderna, dose #2 08/12 pt cc: chills, cough, fever, myalgias, exposure: unknown 08/12 COVID swab, result: not detected 08/13- 08/25 pt symptoms continue 08/19 SARS-COV-2 Variant Sequencing result: pending 08/19 COVID swab, result: detected 09/08 COVID swab, result: detected 09/21 COVID swab, result: detected 09/22 clinically resolved
Moderna injection shot reaction: Severe chills - I had to put 5 blankets on me, severe fatigue, severe headache, extreme muscle pain, joint pain, nausea and fever.  I thought I was going to get paralyzed.  I couldn't lift my arm or hold a cellphone.  I feel dizzy when I get up.   I took tylenol after 24 hours from vaccination time.  And then took another 2  tylenol after 6 hours. It got better after the next day.  And I broke some sweat.  My left arm is still a little swollen and sore today.  4/19/2021
Information has been received from a medical assistant concerning a 65 year old female with no known drug allergies and "long medical history" who on 05-JAN-2010 was vaccinated IM with a second dose of PNEUMOVAX 23 (lot# 663889/0632Y). Concomitant therapy included vitamins (unspecified) and calcium (unspecified) supplements. On 06-JAN-2010 the patient experienced an infection, raised and elevated and red area that looked like it could have developed into cellulitis. Intervention was the physician giving an unspecified treatment. The patient did not have any problems after the first dose of PNEUMOVAX 23 given by another office. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. Cellulitis was considered to be an other important medical event. Follow up information has been received from the medical assistant who confirmed that the patient received on 05-JAN-2010 the second dose of PNEUMOVAX 23, (Lot # 663889/0632Y) IM at 2:50 PM. The same day, the patient experienced 4 cm of erythema, warmth, and pain at the site of vaccination. Later, the same day the patient had worse. The patient was treated with trimetoprim and SEOTRA DS and KEFLEX 5 mg, both for 7 days. The patient had recovered on 12-JAN-2010 from all the symptoms. Further follow up information has been received from the medical assistant, who confirmed that the first dose of PNEUMOVAX 23 was given elsewhere (location, date, lot # unknown). The patient had no problem with that first dose. The second dose was given in the reporter's office on 05-JAN-2010. The reaction happened after the second dose. No cultures were performed. The cellulites was diagnosed based on examination. Antibiotics were given to prevent serious criteria. No further information is available.
This case is a part of 2 cluster cases and is linked to case number 2013-03417 (Same reporter, same vaccine: FLUZONE ID lot number UT4472AA). Initial report received from a healthcare professional on 25 February 2013. A male patient (age at the time of event and date of birth were not reported), had received a dose of FLUZONE ID (batch number: UT4472AA, expiry date 04-10-2013, dose number, route and anatomical site of administration were not reported) on an unspecified date in Flu season September 2012-January 2013. It was reported that, after receiving the vaccine on an unspecified date it was more painful. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was unknown. Follow up information received from a healthcare professional on 06 May 2013. The patient had recovered from the event on an unspecified date. Documents held by sender: None.