chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had experienced anaphylaxis previously, so her allergist asked her to receive the egg-free because he believed he was dealing with an egg allergy. He dosed the patient with prednisone and Zyrtec prior to immunization, and required patient to report immediately to his office upon receiving the immunization, so that he could access nebulizers, EpiPen, diphenhydramine, and steroid
Rash on face, neck, and chest - 5 days treated zyrtec benadryl and topical cream from dermatologist
Patient did not experience an adverse event. Upon documentation, it was realized this patient received a fourth dose, although they did not have an indication to receive a fourth dose.
Starting the 1st week of November, I developed BPPV (benign paroxysmal positional vertigo). It was so severe that I fell over. I gave it some time hoping it would pass; however, it didn't. I called my neurologist who couldn't get me in so I got in with my PCP. They referred me to physical therapy to get the crystal alignment corrected. Eventually this was corrected but I was left with occasional positional vertigo. In January, the BPPV came back so they gave me the exercises to correct that however it still persisted. They determined the BPPV was resolved but the positional vertigo had gotten worse and there is no treatment for it. Its somewhat better now but still very bothersome. I went to the neurologist yesterday who reported they had numerous patients that reported vertigo after the booster dose. I will see my PCP Friday but this is inhibiting my ability to fly (I am a private pilot) and I am unable to dive (I am a certified diver). I am unable to do the two recreational activities that I love to do (dive and fly).
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of RECOMIVAX HB that were exposed to temperatures out of range on 02-JUN2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the event was unknown. NO PQC reported. The case has been linked with the cases (same reporter link) # 1406USA011663, 1406USA012409 and 1406USA012415. Additional information has been requested.
Patient was administered her first dose of the covid vaccine. She appeared nervous but did not indicate a history of fainting or adverse reaction to vaccines. She got her vaccine, stated she felt fine and proceeded to move from the immunization room to the lobby. After a few minutes, her mom started stating that her daughter was having a reaction. The daughter looked pale and felt faint. Mom helped her back into the immunization room. One of the pharmacists got her a ice pack. Patient also had a lollipop and Gatorade. She was not experiencing shortness of breath or swelling of the throat/tongue. After several minutes, her color returned to normal and she felt well enough to return home. I left a message with mom later to follow up but have not heard back yet.
received both the Engerix B and Pediarix vaccines; Adult product administered to child; Fussy; This case was reported by a other health professional via call center representative and described the occurrence of irritability in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 31st May 2020) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Pediarix .5 ml and the 2nd dose of Engerix B adult 1 ml. In February 2020, less than a week after receiving Pediarix and Engerix B adult, the patient experienced irritability. On 20th February 2020, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the irritability, overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the irritability to be related to Pediarix and Engerix B adult.  Additional information was provided as follows: The patient received both the Engerix B adult and Pediarix vaccines on same day, which led to overdose for hepatitis B antigen and adult product administered to child for Engerix B adult. The reporter indicated that the parent of the patient was called to follow up and the parent indicated that the child was fussy.   This was not considered to be unusual because the child had received five vaccines the day before. The reporter consented to follow up. The reporter was unable to provide any additional details.
Telephone call from the emergency room provider Hospital he describes patient as having a very signficant and drug reaction to the pneumococcal vaccination administered yesterday. He is tachycardia has significant swelling in the upper extremity is being treated with IV SOLU-MEDROL and remains in the emergency room at this time. Urticaria, Pruritus and Palpitations.
Headaches started and have not stoped; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) of 5mg, rosuvastatin (MANUFACTURER UNKNOWN) of 20mg, losartan (MANUFACTURER UNKNOWN) of 50 mg used for unknown indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 23Mar2021 at 24:00, the patient experienced headache. It was reported that, the event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events was reported as unknown. The clinical outcome of the event headache was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient had swelling, and warmth at injection site, and a fever for 2 days.
Low Grade Fever, Chills, Headache, Minor Sore Throat, Exhaustion, Diarrhea Started at Waking. Had to leave work at lunch. Went straight to sleep.
This spontaneous report was received from a nurse refers to a 19 year old unknown gender patient. On 30-AUG-2013 the patient was mistakenly vaccinated with a dose of PNEUMOVAX23 (lot# H014561, expiration date: 21-MAR-2014), route and dose unspecified instead of MENACTRA. No adverse effects reported. Additional information has been requested.
started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. The patient's patient medical history and concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday. She stated on Sunday (10Jan2021) that she started feeling like she could not smell and did not have flavor and it was getting worse on Sunday and Saturday. She does not have no fever, no headache, nothing from Covid. She stated she received a Covid test and the test was negative. She called to see if this is a side effect of the vaccine. The patient further mentioned that she has no smell or taste and wanted to know if it is related to the vaccine. She mentioned that she does not have any other COVID symptoms and she had a COVID test that was negative on an unspecified date. The outcome of the events was not recovered.  The following information on the batch/lot number has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were  reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. This is one of the several reports from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:49 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication was reported by reporter.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Diarrhea; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
No adverse effect reported; patient was inadvertently administered a dose of Vaqta that was expired; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # R010369, expiration date 25-MAR-2019 (exact dose and route of administration were not reported) for prophylaxis.  No adverse effect was reported.
8am on March 30, 2023 I took a tylenol cold and flu medication due to a mild cough I had developed overnight.  I felt fine otherwise, no fever.  I was tired but that is nothing really new.  At 9:30am I was at work performing a surgery (veterinarian) and at the end of the procedure I felt weak.  Then acute onset of dizziness and racing heart, followed by syncope.  Hands began tingling and fingers curled up and was unable to move myself up off floor or uncurl my hands.  Transported by ambulance to the nearest hospital ER.   I received IV fluids and a number of tests (bloodwork, xrays, CT, ECG) and all results were normal.  I was released to go home later that afternoon around 3:30pm and wore a Holter cardiac monitor for another 24 hrs.  I also had an MRI of my head on April 20, 2023. I have felt fine ever since.  No other issues.
I was exposed to poison ivy on  5/20/2022 but was not aware of it at the time.  A day or two later I began noticing skin reactions to the exposure.  The adverse event is the extremeness of the reaction, much greater than experienced in prior exposures.  I contacted my personal physician and he prescribed Triamcinolone Acetonide Cream USP 1mg/g.  After application for three days the extreme reaction was not subsiding so my personal physician prescribed Methylprednisolone Tablets, USP 4 mg, 21 tablet course for 6 days.  Basic comfort was restored, but some itching remained, though greatly reduced.  The initial major rashes are recovering but other patches, some seem to be new areas, are flaring up (itchiness without the pimpling) periodically.
patient states she had covid; patient states she had covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: (054550). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient states she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: Patient states she had covid during christmas last year. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old female patient who experienced bad itching rash across her chest, while she received vaccine FLUZONE QUADRIVALENT. The patients past vaccination included FLUZONE QIV in 2003 with no adverse reaction. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any vaccine, other than suspect. On 22-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date and dose not reported via unknown route in the left deltoid. On unknown date, the patient developed a non-serious bad itching rash across her chest (rash pruritic) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was 4 days affected by it and did not want anything to touch the rash. It was not painful just itchy. It is getting better now. The patient did report this to her doctor. Lab data was not provided. Final diagnosis was bad itching rash across her chest. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for bad itching rash across her chest. List of documents held by sender- none.
1.24.2022 Employee called the Vaccine Support line to report symptoms post COVID-19 vaccination. Vaccine Name - Pfizer Vaccine Date - 1.24.2022 / Location: Left Deltoid Booster Dose - Yes Date of Symptom Onset - 1.24.2022 Symptoms - Pain and Swelling at Injection Site, Fever (101F) Home Remedies - Ibuprofen, 400 mg, 1 tablet, taken once today Any Improvement - Yes. Employee stated injection site pain is improved.
Report # 2000028600-1 describes urticaria in a child of unspecified gender who rec'd Engerix-B. Allergies, medical history, and concomitant medications are unknown. The pt is currently being evaluated for allergies. The pt rec'd the first pediatric dose of Engerix-B on an unspecified date. In 1995, the pt rec'd the second pediatric dose of Engerix-B, 1-2 hrs post vaccination, the pt experienced urticaria on the back. symptoms resolved in 1-2 days. As of 9/25/00, the outcome of the event is resolved.
Approximately 1 hour after vaccination, patient felt nauseous, had some vomiting, body aches in upper body (arms and neck, etc). No reaction at site of injection noted. Symptoms resolved within 48 hours.
Severe Shoulder and arm pain began the morning after booster shot.  So far, Emergency Room visit completed an UltraSound and given Flexoril. No affect. Visited regular doctor, prescribed prednisone pack. Helped alleviate pain, but pain came back once pack was gone. Referred to Chiropractor. After two Chiropractor visits, severe pain is still existent.
Pt received flu vaccine at approximately 13:30 on 01/13/04.  Mom returned to office at 16:00-child had 2 hives on right thigh 4x3cm and a "c" shaped hive approximately 2.5cm where shot was administered.  Also 1 hive on right check 1.5x1.5cm.  Benadryl 12.5mg administered per mouth.  Mom to give every 6 hours.
Had a metallic taste in her mouth; That it is interfering with her eating; When the caller had Covid she lost her sense of taste and smell, but it was coming back.; When the caller had Covid she lost her sense of taste and smell, but it was coming back.; This is a spontaneous report from a contactable consumer reported for herself. A 68-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection,Lot number: EN6207) via unspecified route of administration, administered in right arm on 13Mar2021 at 11:15 (at age of 68-years-old) as single dose for COVID-19 Immunization. Medical history includes rheumatoid arthritis, hypothyroidism, atrial fibrillation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Caller states she has received both does of the Pfizer COIVD-19 vaccine and both time she has had a metallic taste in her mouth, so much so that it was interfering with her eating and has lost 10 pounds, She had Covid, but she was told she had no antibodies in her blood. When the caller had Covid she lost her sense of taste and smell, but it was coming back. She got her first Covid-19 Vaccine on 13Mar2021, and about a week after she noticed a metallic taste in her mouth that would come and go. First dose Metallic taste in mouth: On Saturday she got her first shot, and it was during that week that she noticed the bad taste. It was has been ongoing, and some days were worse than others.Patient visited physician office for events for first dose. She had regular bloodwork because of her arthritis. Her doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Patient underwent lab test and procedures include CT sinuses result was unknown on unspecified date. The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Chills and fatigue were noticed in the morning after receiving the vaccine (first dose) the day before.  Time would be approximately 20 hours after receiving the shot.
I developed hives, hands, legs feet and arms. The next day it got worsen, It went into my head, neck, ears and back. So I called my doctor and he stated that I go to the ER. They gave me injection of histamine and steroids. They gave me a script of histamine to take for 10 days. I then got some over the counter histamine and took that. The hives started going away and then they will come back and then go away again. It eventually started to get better.
1120 started with itching on the back.  Given Benadryl 25 mg PO at 1130 per standing orders.  1140  Itching a little better.  1145  Itching progressed to legs - given another dose of Benadryl 25 mg PO per standing orders.   1215 Itching decreased on back and legs.  Advised to call doctor if worsens and take Benadryl as needed.  Allowed to go home.
On 9/22 my daughter had a rash line from shoulder to wrist. On 9/28 another rash line from groin to ankle. Both rashes are on her left side, same side her Covid vaccine was given.  Took her to her doctor (9/28)  who diagnosed shingles.  Prescribed Acyclovir 200mg 5x a day.
Information has been received from a physician concerning a 16, 17 or 18 year old patient (high school student) who was vaccinated with a first dose of GARDASIL. Subsequently the patient passed out in the office. It was reported that there was no reaction after the second dose. The patient's twin also was vaccinated with a dose of GARDASIL and passed out (WAES# 0802USA01944). Additional information has been requested.
This spontaneous report as received from a nurse refers to an 18 month old patient of unknown gender. Medical history and drug reactions or allergies were not specified. On 11-SEP-2014, the patient inaddvertently received one dose of GARDASIL injection (route and lot number were not reported). No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
pt. recieved vaccine greater than 12 hours after being drawn up. MD contacted pt. no adverse event. Pt. declines revaccination
Sweats, hot and cold, arm pain, swollen axillary lymph nodes, heavy eyes started at 24 hours after injection.