chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abd. cramps/abdomen still feels "touchy"; diarrhea; chills; loss of appetite; sore throat; fatigue; Sore injection site; right arm pain; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, thoracic aortic aneurysm, septic shock survivor on 2019, secondary to pyelonephritis and kidney stone, hip and knee replacement surgeries secondary to osteoarthritis and obesity. The patient received unspecified medication within two weeks of vaccination. The patient had allergic to (unspecified ) medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00, the patient experienced sore injection site and right arm pain first 2 days. On 11Apr2021, 3rd day after vaccination, the patient experienced Abd. cramps, diarrhea, chills, loss of appetite, sore throat, fatigue. The patient also reported that, 6th day since vaccination, and she was still not back to 100%, still fatigued, and abdomen still feels "touchy", appetite slowly improving and no fever through all this. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events sore injection site and right arm pain, Abd. cramps, diarrhea, chills, loss of appetite, sore throat and fatigue was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a female between 9 and 18 years of age who on approximately 24-JUL-2008 was vaccinated with a dose of GARDASIL.  The patient developed paralysis immediately after the vaccination.  She was taken to a hospital and diagnosed with transverse myelitis.  She is still in the hospital.  The patient's outcome was unknown.  Transverse myelitis was considered disabling.  No further information is available.
Sudden redness and swelling at injection site with later onset of 103 fever, congestion.
dizziness; fatigue; extreme nausea; This is Spontaneous report from a contactable consumer received via Pfizer. This consumer reported similar events for self and 3 patients (Three friends). This is a third (Friend no 2) of four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. Reporter kept hearing from various sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. Reporter personally was down and out for three days with dizziness, fatigue and extreme nausea and three of his friends had the same thing on an unspecified date. The clinical outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224267 same, reporter and drug , different patient;US-PFIZER INC-202101224288 same, reporter and drug , different patient;US-PFIZER INC-202101224286 same, reporter and drug , different patient
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Itching; This is a spontaneous report received from a contactable health care professional. A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205), via an unspecified route of administration in an unspecified anatomical site on 17Mar2021 (at the age of 34-year-old), as dose 1, single and via an unspecified route of administration in an unspecified anatomical site on an unknown date, as dose 2, single for COVID-19 immunization. On 17Mar2021, during her 30 minute waiting period after the injection, the patient began to experience itching. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, dizziness, facial swelling, lip swelling and tongue swelling. The patient had experienced same itching with the first dose of vaccine. Patient received treatment after first dose with antihistamines benadryl and pepcid. Follow up response to the treatment was fair. Similar to last time, patient was given benadryl 50 mg and pepcid 20mg for itching, after the second dose of vaccine. Patient was not drowsy at the time of discharge. The clinical outcome of the itching was unknown.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added. Onset date removed for event as the event occurred with both dose 1 and dose 2.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 024M20A), on 17Mar2021 as dose 2, single (Lot number: 001B21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 048C21A) for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: PK9893) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: no other medical history. The patient took Paxlovid from 02Mar2023 to 07Mar2023. Other medication in 2 weeks product calcium; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109918 Same patient, different drug/event;
Swollen, hot vaccination site. Rash, numbness in arm. Heart palpitations.
Vaccine was administed at pharmacy and within 30 minutes developed chest pain.    45 minutes after receiving vaccine MD called.  Advised to go to ER.  Pt given Epi, Benadryl and Steroids.
Mom called and stated 3 hours post vax, pt broke out in a full body bright, red rash. No breathing problems, low grade fever. Mom states she's taking him to the ER and will call later with a report. Mom states child is feeling fine, except for the rash. On 2/16/00, called and spoke with mom at 15:34 and she stated that she had just returned from MD and he stated that the rash is not caused by the vaccines received on 2/15/00 but that the rash was caused by an allergic food or environmental etiology and he will be doing further testing into allergies.
Patient was given first Pfizer dose and ten minutes later felt dizzy and was extremely pale and cold. Patient's blood pressure was checked and was within  normal limits. Patient was excorted to vehicle with a wheelchair. A courtesy call was performed a couple hours later and patient stated they still felt dizzy when standing up but would wait to see if symptoms would pass.
Information has been received from an RN concerning an unidentified pt who was vaccinated with varicella virus vaccine live. Subsequently, the pt developed hives and erythema from the shoulder to the elbow. It was noted that the pt developed hives "very quickly after receiving the vaccine." The pt sought unspecified medical attention. Additional information has been requested.
I am responding to your request to describe my reaction to the RSV vaccine I received in September. I received the injection at clinic on Thursday afternoon and had no immediate problems . On Sunday into Monday I experienced increasing fatigue and growing aches in all my joints in ankles, shoulders , knees and elbows. These issues subsided after about 48 hours. However, I began to experience some gum sensitivity on the Monday following the injection and by Wednesday I visited my primary care doctor and he prescribed a mild antibiotic. However , by Friday the sensitivity to my gums and tongue became very painful to the point I could not eat any sold food w/o significant discomfort. I went to Urgent Care and they thought I had Thrush.the prescription he ordered wasn?t effective ,so on Monday on went to my dentist. She very quickly recognized the problem as an autoimmune response . She prescribed prednisone for 5 days and by the third day the symptoms were subsiding. After about another 10 days the swelling and discomfort was gone. I hope this is detailed for any report. I have never had any negative reactions to previous vaccines.
30 min following immunization leg of inject swelled red & hard from hip to knee; Refused to walk on it x 1.5 days; Swelling slowly resolved over 2 wks; t100 x 3 days;
A non-serious spontaneous report of H1N1 vaccine given to a person greater than 49-years-old was received from a registered nurse concerning a 54-year-old male. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Fever 101 degrees F and chills within 24 hours of vaccination - lasted 48 hours. Injection site - swelling and burning, swelling subsided but burning sensation still active as of 10/28/15. Took TYLENOL first day.
Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 minutes after waking up I passed out and fell while taking a shower. I have no history of passing out for any reason and have had no side effects with any other prior vaccinations.
Extreme tinnitus developed 48 hours after first shot. ENT doctor prescribing prednisone.
MENSTRUAL ABNORMALITIES; DEBILITATING FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual abnormalities, and debilitating fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual abnormalities, and debilitating fatigue. This report was non-serious.
Chills; Headach; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196, Expiration date was not reported), via intramuscular route of administration, in Arm left, on 26Jun2021 at 13:00 (at the age of 83-year-old), as a single dose for covid-19 immunization. The patient medical history included UTI from 19Jun2021 to 29Jun2021. Concomitant medications included Levofloxacin 500mg for UTI from 19Jun2021 to 29Jun2021. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0186, Expiration date was not reported), via intramuscular route of administration, in right Arm, on 02Jun2021 at 13:00, as a single dose for covid-19 immunization and experienced rash, dizzy. Vaccination facility type was reported as Pharmacy or drug store. There was no prior vaccination. On 27Jun2021, the patient experienced chills and headache. Relevant tests included Urine culture on 19May2021 with a result of UTI (Units: 500 mg). Outcome of the events was unknown.
chills / same as before but no period; fever / same as before but no period; Sore arm / same as before but no period; Achy joint / same as before but no period; Nausea / same as before but no period; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 016B22A, 007B21A and 040A21A) for COVID-19 prophylaxis.     The patient had not been diagnosed or tested positive for COVID-19.  The patient's past medical history included Stomach cancer (ongoing checkups) in 2020 and Tumour excision (Stomach cancer, tumor removed, ongoing checkups) in 2020. Concurrent medical conditions included Eczema since 10-Jun-1958, Blood pressure high, Acid reflux (esophageal), Restless leg syndrome (RLS), Drug allergy (Oxycodone), Allergy to moulds and Food allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, LOSARTAN and AMLODIPINE for Blood pressure high.   On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 8:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period). At the time of the report, CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period) had resolved.            Dose 4 was given at 01:00pm. Patient was taking an unknown concomitant medication for RLS. Treatment information was not provided. The event had not caused patient t seek medical care.   This case was linked to MOD-2021-074747, MOD-2021-074721 (Patient Link).
Went to Dr office and was found to have bradycardia, hypoxia, and resp distress.  Sent to ED and was found to have complete heart block, uncontrolled hypertension, worsening resp distress.  Adm to ICU for plans for permanent pacemaker placemen, now placed. Patient received COVID vaccine 2 days prior. Specific vaccine information unknown since administered outside of facility.
Not able to sleep last night; Not able to get up; fatigue; Headache; Nausea; High fever,  Fever of 107°F,  Fever of 100.2°F; Muscle pain; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever,  fever of 107°f,  fever of 100.2°f/pyrexia, muscle pain/myalgia, chills, fatigue, headache, nausea, not able to get up/bedridden, not able to sleep last night/insomnia.  The patient's medical history included arthrosis, arthritis, and osteoporosis. Concomitant medications reported were blood thinners, etanercept, Osteoporosis medications.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) on 20 Feb 2021 in the right arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021 8 hours after receiving the vaccine the patient had high fever, muscle pain, chills. No one told her that she could have side effects. In the morning had extreme fatigue, headache, nausea, and is not able to get up. She wanted to know what should take to treat the symptoms because she is an old woman and is not able to go to hospital. On Sunday she had fever of 107°F. Caller took Tylenol to treat the symptoms because no one give her any advice on side effects and what to do. For the rest of the day, caller had fever of 100.2°F. She was not able to sleep last night and stated she felt like having the virus again. Treatment for the events include Paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event experienced high fever, fever of 107°f, fever of 100.2°f was resolved on 22 Feb 2021. The outcome of the events muscle pain, chills, fatigue, headache, nausea, not able to get up, not able to sleep last night was not resolved.
no adverse event but patient received the incorrect vaccine.  Should have received the Pfizer Bivalent Booster
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old male patient who received a dose of 0.5 ml of FLUZONE HIGH DOSE (lot UJ004AA and expiration date31-Mar-2019) via unknown route in the left deltoid on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. The patient did not report any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Patient received Pfizer Pediatric dose 0.2mL undiluted.  Injection site arm pain and mild fever 99 F.
Bilateral thalamic stroke, symptoms began 5 minutes after vaccination. patient presented to hospital 36 hours later.
We were at the playground one day and then she started screaming and clutching her ear. The next morning her ear was full of dried up blood. On 7/8/2022 I took her to her pediatrician and they said it was likely a ruptured ear drum possibly caused by a bad ear infection. They're were no symptoms prior to it happening. She had no fever, sniffles, or a sign of a cold. She was prescribed amoxicillin. She also tested positive for COVID-19 today. She is sneezing, fussy, clingy, fatigued, tired, and has diarrhea.
same night at around 9pm she had fever of 102 degrees F; vomiting; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was goose egg on arm and it's red and warm to touch and painful if touched; injection site there was  goose egg on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (same night at around 9pm she had fever of 102 degrees F) and VOMITING (vomiting). In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched). At the time of the report, VACCINATION SITE WARMTH (injection site there was goose egg on arm and it's red and warm to touch and painful if touched), VACCINATION SITE MASS (injection site there was  goose egg on arm), PYREXIA (same night at around 9pm she had fever of 102 degrees F), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) and VACCINATION SITE PAIN (injection site there was goose egg on arm and it's red and warm to touch and painful if touched) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 (High) fever of 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Patient had stated that whether she just take Benadryl for events.