chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had tinnitus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; NASONEX; ALBUTEROL [SALBUTAMOL]; PULMICORT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "she had tinnitus."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was diagnozed with borderline type 2 diabetes in early 2020.  I test once or twice a week, and have managed to reduce my average blood sugar level from around 130 to 100.  Beginning approximately 10 days after the first dose of the Moderna COVID-19 vaccine and lasting until approximately 10 days after the 2nd dose, my blood sugar average jumped to over 117.  In the month since, my average blood sugar has dropped to under 98.
On 4/19/21, Pt began with pain in her left leg.  Pain continued to worsen so that she could not sleep at night and she became unstable on her feet.  On 4/23, she developed a 102 degree fever, severe nausea and severe abdominal pains and she drove to Hospital ER on 4/24.  She was diagnosed with Deep Vein Thrombosis behind her left knee.
This spontaneous report as received from a female consumer refers to a 88 year old patient (reported as husband). On an unknown date in 2011 the patient was vaccinated (reported as we got shingles shot) with ZOSTAVAX (dose, route and lot number not reported). The reported stated that the patient has got shingles "bug" since an unknown date in 2011. At first he experienced some discomfort on his face/jaw area. He visited Emergency Room and a dentist to diagnosed the cause of pain. The consumer stated that on ER they did not know what was causing the pain but they suggested it might be shingles. It was reported that the dentist stated that patient looked like he were coming down with shingles. On the next day he was "broken out" down the left side of his face from the top of his head to his lip area. The patient was pretty miserable and finally found relief with CAPZASIN. On that time "the shingles were" all around the eye area. It was also reported that patient's eye socket was still painful, red area on the left side still bother him. In December 2012 (reported as on Christmas 2012) the pain still continued to bother the patient (reported as still has a lot pain in the area). The left eye was affected and patient could not read for too long without it hurting. He also used iced packs that helped numb. At the time of the report patient state for the shingles were all around the eye area, pain bother him, cannot read for too long without it (left eye) hurting was not recovered and for miserable was unknown. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   This case referred to Patient 2 out of 4 patients.  No concomitant medications were reported.  Reporter was asking how long they should wait before they can give the Spikevax to patient who had Covid in Sep2023. HCP stated that patient had previous Moderna Covid-19 vaccines.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748266:Patient 1 out of 4
Started with ringing in left ear on 4-10-2021, upon waking.  Lasted about 5 hours before going away.  Then the next day, a  different form of ring/buzzing started and has not gone away to date.  This ringing/buzzing is more prominent in my right ear.  I also feel a tight feeling in my head most of the time.
She experienced normal soreness the same day. The pain persisted and worsened until one week later when she could no longer lift her right arm over her head. She visited and orthopedist who diagnosed her with adhesive capsulitis ("frozen shoulder") that the doctor said can be caused by vaccines. The pain has continued but improved. On 10/29/09 she reported being about 90% recovered. Requested vaccine without thimerosal.
Extreme Fatigue for 6 days Unable to stop sleeping. First 24 hours of the event was sleep with only brief wakings (5 to 10 minutes). The following 5 days 16 to 20 hours of sleep each day.
bladder infection; This is a spontaneous report from a contactable consumer (patient's spouse). A 65-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get his second dose on 16Jan2021 (reported as "this coming Saturday"), but in the meantime the patient came down with a bladder infection and was taking Cipro 250 mg twice a day. He started on 09Jan2021 (reported as the past Saturday night) and finishes on 7am on 16Jan2021 Saturday, the day of the second vaccine. The reporter did not know if the patient should take it that day or wait or move the vaccine a few days out. He would still be in the 19-23 day (window). The reporter didn't know if it would fight off the COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Zobie Human COVID vaccinated gone bad; Golf ball size area on top center of skull; Heart layer of shingles; Flu; Liver bladed knife-like line length liver; As for kidneys one pea size spot in each; Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu) and HEPATOMEGALY (Liver bladed knife-like line length liver) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature). At the time of the report, FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature) outcome was unknown. Not Provided          No concomitant medications were reported. It was reported that the patient had an unknown cellular mutation from the two shots of Moderna vaccine and its self-development in the different areas of human body and high temperature would kill brain area and illness. It was also reported that death would now be due to vaccines and booster ordering. No treatment medications were reported.
Started itching on my hands.  Spread systemically.  Hives all over body and face including feet. Took Benadryl and applied  hydrocortisone without relief.  Started a steroid.  No improvement yet.
1. Severe headache & swelling of throat 2. Severe itching - mouth, ears, eyes 3. Swelling - mouth, eyes, tongue 4. Fever - 101 6. Severe burning along with swelling - mouths, eyes, tongue 7. Drainage - eyes 8. Duration 18-20 hours 9. Reported to medical clinic but was told by clinic staff symptoms could not be the result of flu vaccine - the only side effect might be slight rash at injection site - even though accompanying literature about vaccine said otherwise.  Was instructed to take something for upset stomach since symptoms were likely something else.  Could take allergy medication if I had some at home.  No offer for other assistance. 10. Found allergy medication and double-dosed every 4 hours.
Received first flu shot on 12/2. Approximately six hours later developed muscle aches, extreme fatigue, bleeding gums, swelling of tissue under the tongue, barking cough and redness in eyes. Symptoms resolved after 24 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2023) Positive, notes: Tested positive this morning. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 17Jan2023 to 23Jan2023.
13JUL93 per mom 3PM pt site not red but below knee red, swollen; pt did not record any fever higher than 99.0F; mom did call pvt MD to tell of reaction; shrill crying for 3 hrs;
Symptoms Fever, chills, headache, joint pain, muscle pain, fatigue, nausea Lasting almost 3 days
This spontaneous report was received from a company representative via a registered pharmacist refers to a 66 year old female patient. On 25-JUN-2014, the patient was vaccinated with ZOSTAVAX lot# J014566, .65 ml, subcutaneous in the triceps on her left arm. On 26-JUN-2014, "within 24 hours", the patient experienced that the injection site was warm to touch with no pain. No treatment given. The patient told the pharmacist that the event "resolved on fourth day post vaccination". No information regarding the patient's medical history or concomitant medications was provided. Additional information has been requested.
Gall bladder surgery; missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment; swollen lymph nodes; body ache; Vomiting; nausea; fever; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER OPERATION (Gall bladder surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 12-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment). On an unknown date, the patient experienced GALLBLADDER OPERATION (Gall bladder surgery) (seriousness criterion hospitalization). On 12-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed appointment for second dose/scheduled to received second dose 12 Feb 2021 but was unable to keep the appointment) had resolved. At the time of the report, GALLBLADDER OPERATION (Gall bladder surgery) had resolved and LYMPHADENOPATHY (swollen lymph nodes), MYALGIA (body ache), VOMITING (Vomiting), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment for chills, fever, nausea, vomiting, body ache, fatigue, and swollen lymph nodes included paracetamol.  The patient was scheduled for her second dose on 12 Feb 2021, but was unable to keep the appointment because she went to the emergency room and then had gall bladder surgery. By the time her surgeon had released her,  it was past her appointment time.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The event of gallbladder surgery was added.  Narrative updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The events are assessed unlikely related to product.
Localized redness (no pain/pruritus) to chest and distal lower extremity paresthesias; lower extremity paresthesias promptly resolved. Redness improved upon observation/close monitoring from 4:48 PM to 5:38 PM. Denied other systemic symptoms. She had taken benadryl 2 hours prior to arrival. Advised taking benadryl again when she got home if the redness was still apparent. Told her to go to the ED if she develops shortness of breath, respiratory distress, tongue swelling, rash, or hives.
This alleged reaction may have been reported previously (10/07?) on a VAERS Report by the administering Nurse.  Mother states that shortly after her child received the vaccines in the Immunization Clinic, she breastfed her and within 5 minutes the mother broke out in an itchy rash.  The mother returned to the clinic the following day (10-25-07) and a generalized rash on the mother was observed by the nurse and Dr.  She was referred to the ER and hospitalized (?Where).  Mother returned to the clinic yesterday (2-27-08) and states she is now bringing the child to clinic and her child, nor she has had any further reactions to any vaccines.  She is interested in how she can receive financial compensation and was referred to the Nat'l Vaccine Injury Compensation Program.  3/14/08 Reviewed ER medical records which reveal patient seen 10/25/07 for development of hives, itching & SOB after breastfeeding infant following vaccination.  Tx w/steroids & Benadryl.  Improved & d/c to home on continued meds.   FINAL DX: allergic reaction. Had worsening s/s & returned to ER on 10/26/07 w/generalized red raised itchy rash.  Was taking meds as rx & not breastfeeding as instructed on 10/25.  Tx w/stronger steroids & benadryl around the clock.  Improved & d/c to home.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: ELC9231), in right arm, on 17Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Apr2022. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (24Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid for COVID-19. Treatment start date was 18Apr2022 and stop date was 22Apr2022. The patient tested negative on 24Apr2022 and returned to work. On 27Apr2022 felt ill and tested positive. Was ill for two weeks.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
Provider Summary" 72 YO female with PMH of chronic obstructive pulmonary disease, hypertension, hyperlipidemia, diabetes, coronary artery disease s/p multiple stents, presented with 4 days of fatigue, generalized weakness, 2 days of nonbloody diarrhea, intermittent shortness of breath and chills.  Patient reports that she went to family's baby shower last Sunday (6/5/22) and there were multiple family members at the function who were COVID positive.  Patients symptom onset was very next day (5/6/22).  Furthermore, she reports she has been having lightheadedness, dizziness when she tried to walk and also experienced some unbalanced gait.  Patient denies any fever, sore throat, nausea, vomiting, chest pain, palpitations. Patient needs vaccinated for COVID but not boosters. She confirmed that she had the flu vaccine. Patient is a current smoker half a pack of cigarette almost 40 years she denies any marijuana or other recreational drugs. she drinks alcohol occasionally."   Hospital Course:    On admission to general medicine team patient was started on Remdesivir (4 doses total) decadron (x10 days), vitamin D, C and zinc. She required 2L of oxygen via NC but was able to be discharged on home air. Patient had a run of VT for which she was treated with IV metoprolol. Discontinued her atenolol for PO metoprolol and set up for out patient cariology follow-up with Dr.
Intermittent redness left deltoid -> elbow. Discomfort at injection site only. Referred by this nurse to PMP f/u telephone call 10/17/11: Redness resolved today, did not see PMP/oncologist. Encouraged her to speak with physician prior to next year's flu vaccine season regarding reaction.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Primary diagnosis was acute on chronic respiratory failure with hypoxia and hypercapnia.
Right after vaccine was given into LUA, patient passed out. Patient was moved from a chair to a wheelchair and then to the EMS area. Vitals were taken and patient assessed.
It was a very busy setting and we waited for an hour or so, she aimed the vaccine diagonal and then straight in my arm. She did it with one hand and did it very carelessly.
Information has been received from a physician and an office administrator concerning an approximately 59 year old male patient who was indicated for ZOSTAVAX (Merck) in 2008 and was vaccinated with 2 doses of VARIVAX (Merck) (lot number not reported) mistakenly by the provider (dates unspecified).  The physician confirmed that he administered VARIVAX (Merck) according to the prescribing information interval.  There were no adverse effects reported.  Unspecified medical attention was sought.  At the time of the report, the outcome of the patient was not reported.  Follow-up information has been received from an office administrator who reported that she did not have the lot number.  This is one of several reports from the same source.  Additional information has been requested.
C/O pain at injection site, area of redness noted about 50mm x 70mm, 10mm swollen area, warm to touch. Symptoms began 10/17/12 PM, injection was 10/16/12, site of varicella vaccination.
Vaccination given 5/3; evaluated 5/6 and treated for local reaction with BENADRYL.
15SEP95 T=102 swollen glands, pain on tr side of body, pain on breathing;
Had chickenpox (varicella) vaccine at age of 12 months. Had lesion (10-15) atypical with only a few being vesicular and 1 lesion. Scabbed over. R/o atypical chickenpox.
The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022; No adverse event; Patient received expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     Patient has no Allergies.  It was unknown whether patient ever had COVID positive test or diagnosis.     On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine) and PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022).    No concomitant medications were reported. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine It was in the original box, but it was the last vial left.  The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 10-Aug-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648029 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648029:Second patient case