chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT BEGAN TO C/O TONGUE NUMBNESS, TOP OF MOUTH SWELLING AND TONGUE GETTING "THICK", PT GIVEN 50MG OF BENADRYL IM  MONITORED FOR 40 MINS, RIDE CAME AND GOT PT, PT EDUCATED ON S/S OF ANAPYHYLACTICS AND WHEN TO CALL 911 SUCH AS INCREASE TONGUE SWELLING, SHORTNESS OF BREATH, HIVES. PT VERBALIZED UNDERSTANDING.
Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently one hour after the patient received Gardasil, the patient's hand and arms were cold. Subsequently on an unspecified date, the patient recovered from hands and arms were cold. The causality of the event was not reported. Additional information has been requested.
skin allergy; skin allergy; This case was reported by a pharmacist via call center representative and described the occurrence of yeast infection of the skin in a patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced yeast infection of the skin and allergic reaction to drug excipient. On an unknown date, the outcome of the yeast infection of the skin and allergic reaction to drug excipient were unknown.   It was unknown if the reporter considered the yeast infection of the skin and allergic reaction to drug excipient to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient tested positive for yeast with skin test. The patient read in the package insert (PI) that administration of Twinrix was contraindicated for those who have allergies to yeast, and was calling to get additional information or guidance on how to proceed with dosing. The patient was not sure if the skin test was positive prior to receiving the vaccine or after receiving the vaccine.      Lab Comments: On an unknown date, the lab test was performed
Weak and pain in the arms and legs. involuntary movements of the fingers of the hands.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 27-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
UNKNOWN, PT JUST CALLED AND INFORMED THE PHARMACIST ON DUTY THAT SHE WENT TO THE HOSPITAL AGAIN AND HAD TO USE AN EPI-PEN DOSE
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.    Vial was moved to fridge on 01-Dec-21. Vaccine was administered past the 30-day from the initial storage at 2 degree Celsius to 8 degree Celsius.
Patient was giving a .25mg does of Moderna,  after it was brought to my attention that the vaccine was past the time (expired).  No known reaction.
BODY ACHES; WAS IN BED ALL DAY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, was in bed all day, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the was in bed all day, body aches and fever was not reported. This report was non-serious.
Headache, Myalgia, Diarrhea, NauseaVomiting, fatigue Narrative:  Other Relevant History:
5day p/vax pt devel fever 100-101, weakness, loss of appetite, increased sleepiness & fatigue. sx continued x 3 wks; admitted to hosp; gradually recovering
1st Dose vaccine 1/29/21;  Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA,  d/c'd home. ; 2nd dose vaccine 2/19/21; seen in ED 2/22/21 for SOA, congestion, N/V, and Left flank pain x 3 days; admitted to hospital from ED 2/22/21 Dx: 1. Epigastric pain  R10.13 789.06 2. Elevated brain natriuretic peptide (BNP) level  R79.89 790.99 3. Dyspnea, unspecified type  R06.00 786.09 4. Abnormal CT of the abdomen  R93.5 793.6 5. Hypomagnesemia  E83.42 275.2 6. Hypokalemia  E87.6 276.8 Currently still admitted to hospital at time of this report.
Patient wakes up in the morning, sometimes during night also due to ringing sound in ears; patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears; cannot sleep well; Weakness; Dizziness; 6 hours later started with pain in the arm; Couldn't stand; Patient was sick for 2-3 days; Increased fever, tmeperature/fever; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (6 hours later started with pain in the arm), DYSSTASIA (Couldn't stand), ILLNESS (Patient was sick for 2-3 days), PYREXIA (Increased fever, tmeperature/fever) and ARTHRALGIA (Knee pain). On an unknown date, the patient experienced TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness) and DIZZINESS (Dizziness). The patient was treated with ACETAMINOPHEN for Pyrexia, at a dose of 1 dosage form. On 02-Mar-2021, DYSSTASIA (Couldn't stand) and PYREXIA (Increased fever, tmeperature/fever) outcome was unknown. At the time of the report, TINNITUS (Patient wakes up in the morning, sometimes during night also due to ringing sound in ears), PERFORMANCE STATUS DECREASED (patient is having problem of Tinnitus which is impacting patient's performance, Patient cannot perform well with shouting sounds in ears), INSOMNIA (cannot sleep well), ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN IN EXTREMITY (6 hours later started with pain in the arm), ILLNESS (Patient was sick for 2-3 days) and ARTHRALGIA (Knee pain) outcome was unknown.            No concomitant medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Contact details, event details were added.; Sender's Comments: na
No adverse symptoms. HIB mixed with MMR diluent, vaccine will be readministered correctly.
It started after my third dose on November 2021, I had the vaccine around 10:30AM and noticed chills, fast heart rate and headache. I noticed it ever since; I ended up in the ER November 2021. Had my second booster November 2022, it began to get worst again so I went to see Dr. and he sent me to get an echocardiogram on February 2023 because my heart rate was 115BPM and I'm still waiting for the results.
Odd Joint Aches; Stomach pain; Felt like an elephant was sitting on her chest, she thought she was having a heart attack.; chest pain is not as bad but it is still ongoing off and on for the past 7 weeks/generally at night but sometimes during the day; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6200), dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history included tennis elbow (20 years ago). The patient previously received first dose of bnt162b2 (Lot/Batch number: EL3247) on 27Jan2021 for COVID-19 immunization and old shingles shot for shingles and experienced arm swelled up like a baseball and got really hot (it was a long time ago probably 7-10 years). The patient's concomitant medications were not reported. The patient neither had any history nor took any other products. No additional vaccines administered on same date of the pfizer suspect. The patient felt like an elephant was sitting on her chest, she thought she was having a heart attack and chest pain is not as bad but it is still ongoing off and on for the past 7 weeks/generally at night but sometimes during the day on 18Feb2021 at 02:00, stomach pain on 28Feb2021 and odd joint aches on 01Mar2021. She further clarified that her chest pain isn't as bad, it doesn't feel like she is having a heart attack. The tennis elbow is back sometimes and then she will work out and then her knee hurts and she doesn't have knee problems. States it comes and goes. The patient states it is odd because she knows 4 other people that are having same thing. States 1 had the Moderna and 2 are Pfizer, and 1 had the Johnson and Johnson. They all felt like they were having heart attacks in the middle of the night. The patient was treated with Nexium and states she can only eat oatmeal, bananas, chicken and rice. She neither visit the emergency room nor the physician office due to the events. She is very healthy and in good shape. She called her physician's office and they said to go to the ER or a cardiologist office. There was no family medical history relevant to the adverse events. The outcome of the event felt like an elephant was sitting on her chest, she thought she was having a heart attack was unknown and was not recovered for the rest of the events.  No follow-up attempts are needed. No further information is expected.
1 hour after Twinrix - severe migraine headache, neck pain and nausea. Took PERCOCET (is a pharmacist). Duration of symptoms 16 hours. Resolved next day am. Considered ER but did not go.
Pt states that several days post administration of ZOSTAVAX she had trunk pain during the night which kept her awake.  Today (11-3-08) she reports rash around her midsection on left side which is intermittently painful.
Exactly one week after receiving Moderna Vaccine the vaccination area became itchy, red, hot and a sweliing appeared  This lessened and dissipated over the next few days
not yet gotten the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 8 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient reported no symptoms. She would get the second dose as soon as possible.  No other information to report. The reporter did not consent to follow up.
Red, itchy rash on face appearing that night = 9/19/12 (no rash on vaccination arm). 9/20/12 = Asked pt to take BENADRYL.
Administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) Antibody numbers were in the 800-900 range.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient did not report any adverse events or symptoms post 24 hours after vaccination.
CHILLS, NO FEVER, MUSCLE ACHES THROUGH WHOLE BODY, INJECTION SITE TENDERNESS/PAIN, FEELS TIRED STARTING AT AROUND 2 PM 3/4/17 AND CONTINUING THROUGH TODAY 3/5/17. TAKING 3 NAPROXEN TABLETS PER DAY. I ADVISED ADDING TYLENOL AND FOLLOWING UP WITH DOCTOR MONDAY 3/6/17 IF WORSENING, AND FOLLOW-UP WITH PHARMACIST TUESDAY.
2 days p/recd Td/flu shot had an asthma attack on 10NOV91 & was hospitalized;
Clinic 1 (28 days ago) administered Moderna to 17 years old, the clinic lead.  notified me today,01/27/21, that she was in the process of doing data entry for the 2nd dose of Moderna COVID vaccine, and she noticed that the patient is 17 year old. When the data entry was done for the first dose on 12/30/20, the prescription went through and the pharmacist,  verified and administered the vaccine without noticing that the patient is younger than 18 years old.  The mother, , did consent for the first dose. The clinic lead, , explained the incident to the mother, , on 01/27/, the mother, did consent and asked for the 2nd dose of COVID vaccine to be administered to her daughter,  The patient, is fine.
I administered 5 days early for the second dose of covid19 (Moderna) at 11:50am 5/20/2010 His first dose was done 4/29/2021. He did not has any side effects for second dose yet.
My skin feels I as I have applied Bio Freeze on it. Most common site is over both shoulder area but it can appear randomly on the back, chest, and abdomen area. It is a lot less intense as time passes but certainly not a normal feeling. Medically speaking it feels like it is coming from subcutaneous nerves.
PATIENT WAS TO RECEIVE MEN B VACCINE AND THERE WAS A LOT OF DISCUSSION WITH MOTHER ABOUT PATIENTS HPV SERIES WHICH NUMBER 3 IS NOT DUE UNTIL FEB 24TH. IN ERROR HPV WAS GIVEN INSTEAD OF MEN B.
About 10-12 minutes after receiving the vaccine, it felt like my heart started to beat fast.  I placed my hand over my chest and I could feel it beating. With a couple minutes I began to feel a little dizzy/light headed. Then a wave of cool came over my body and I was feeling better. I was a little shaky after that. I did not report the syptoms at the time, because I was uncomfortable raising my hand unless I was sure I was really having a serious issue and it did not seem to escalate from there.
Symptoms started 7/22/21: constant nausea, frequent burping, can only eat very small meals, feel full fast, reflux (burning back of throat), mid epigastric pain with intermittent pain left upper abdomen, occasionally right upper abdomen, diarrhea/loose stool.  All symptoms persist to the date of this submission. Daily prilosec and tums with varied relief.
10 minutes after vaccine patient developed pruritis rash arms and legs . 25 mg of benadryl provided with rapid improvement of the rash and pruritis. Patient was discharged home, patient and family were advised to consider Benadryl prior to second dose administration.
Anxiety, flushed, hyperventilation, Nausea, Vomiting, and Chest Pain, stated bumps
Experienced total loss of smell and taste two days after second dose on 3/17/21.
Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose by on site healthcare person then released. Numbness subside by next day except near site. Next day grouped hives on whole L leg appears then disappears 2-3x in row for 1-2mins. On & off Chills and goose bumps on L side of body & fatigue, which dissipated after about 1-2wks.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose number unknown, single (Lot number: er8732), in left arm and on 19Apr2021 as dose number unknown, single (Lot number: ew0164) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Oct2021 as dose number unknown, single (Lot number: 032f21a), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: took Paxlovid from 06Jun- 11Jun had negative test; (19Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Dizziness, Headache & Fever Employee became dizzy and experiences hot flashes 30 minutes after receiving the second vaccination. Had elevated temp of 99 F which returned to normal within 2 hrs. No rash, no rapid heart rate, not chest tightness or cough. No other symptoms.
2 days post vaccine, 09/02/2021, I felt like my heart was beating really fast. Very uncomfortable. I felt my heart speeding fast at times, on and off. I called the doctor on Friday, 09/03/2021 that week and made an appointment on Monday, 09/06/2021, the doctor diagnosed me with Premature ventricular contractions (PVC).  On 09/10/2021 my heart was going really fast. I called the nurse and she told me to go the emergency room. At the emergency room, they said I am not having a heart attack. They checked for inflammation of the heart and did all the test they needed to do, and they confirmed I had PVC.  My cardiologist told me it could be a cause of the vaccine. My cardiologist was upset at me for taking the vaccine. The doctor told me to eat a banana and an apple and not to eat too many salty foods. The reason I took the 3rd dose is because I have diabetes and high blood pressure. My heart beats normal and then it skips and then it starts going again and then it skips again.  My cardiologist said it's not skipping regularly; he will just keep an eye on it. I don't know if my PVC was caused by the vaccine or because I started taking the double dose of the Glimepiride. I stopped taking the double dose of the Glimepiride, I went back to 1 mg per day.