chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives all over body; UTI; huge cold sore on nose; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration at Left Arm on 26Jan2021 17:30 (at age of 31 years old) at single dose for COVID-19 immunisation. Medical history included allergies: Sulfa. Concomitant medications included fluoxetine hydrochloride (PROZAC); vitamin d nos; clarithromycin (MACROBID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ek9231) on 07Jan2021 05:30 PM at left arm at 31 years old at single dose for COVID-19 immunisation. No COVID prior vaccination. Nasal Swab on 09Mar2021 was Negative. On 26Jan2021 09:00 PM, within 5 hours of getting my second vaccination, patient broke out in hives all over body. Patient called doctor and was prescribed steroids to help with the hives as antihistamines were not helping. A few days later patient woke up with a huge cold sore on nose which patient never had before. The same day patient was experiencing symptoms of a UTI and was prescribed Macrobid which had taken several times before. Within an hour of taking it patient's body was covered in hives and throat started to close. Patient immediately went to urgent care where received a shot of Benadryl. Patient was confident this reaction would not have happened if patient had not had this vaccine. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment (Prednisone and a shot of Benadryl) received. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hives, UTI, Cold sores cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On Tuesday, 9/24/02, received HBV then on Wednesday and Thursday, 9/25 and 9/25/02, 2/3 of hair on top of head fell out at root. Went to DR who performed complete thyroid work-up - normal.
Patient experienced high fever, sore arm, redness at injection site and headache from PNEUMOVAX 23 and FLUZONE HD shots. Patient did not inform pharmacy until evening of 9/12/18. On 9/6/18 after receiving immunizations she had trouble sleeping and tightness around head. Then the next day had a fever of 102 with injection site red and painful. On 9/8/18 fever down to 100 and on a liquid diet. As of today 9/12/18 patient is feeling better but still soreness and redness at injection site. Patient states that she does not want to seek any medical attention and believes this will resolve on its own.
My left arm did turn red and ache a bit at the injection site later in the day of the injection. Sunday morning I woke up very itchy with hives all over my body. I have been taking Benedryl capsules and applying cortizone cream with little relief.
Employee states within 1-2hrs of of injection, increased need to urinate (every 20 min since shot), pain in back on both sides (kidney area). Today also has nausea and increased thirst. No symptoms before shot of any problems. Temp 98.8 degrees
This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2021, the patient received Shingrix. In November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix reconstituted with sterile water instead of with the diluent portion of Shingrix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021247311, reported by same reporter for different patient. Sender's Comments:  US-GLAXOSMITHKLINE-US2021247311:same reporter, other patient.
On Wednesday night I started to sneeze. I had a dry intermittent cough and a slight headache. I had no fever, but I had body aches. I also had a sore throat. I completed a home COVID-19 test on January 04, 2023, and it was positive. I called my doctor, and we discussed my symptoms. He prescribed PAXLOVID which I started taking yesterday. I also used over the counter medication. Last night my fever was 101.0, with coughing and chills. I do feel better than I did yesterday.
Pt devel nausea, malaise & fever 3 days p/vax w/Hep B; no further details were provided;
On 7/21 received 4 vaccines - 2 in each leg. At night the following symptoms started and continued for 3 days: fever 105, loss of energy, loss of appetite, dizziness, diarrhea, accelerated heart beat even if no fever, red protruding hives, difficulty breathing, even with TYLENOL fever only went down to 100 degrees. Taken to ER on 8/27 given more TYLENOL and finally fever went down. Symptoms continued over weekend, larger red hives. Called doctor on 8/30 no doctor visit. Today the symptoms are diminishing, no longer has rapid heart beat. Some vax were not documented on vax record by provider might have receive double doses.
Client was asymptomatic and responding to questions during the first administration of first two vaccines, Men B and Hep A. Client exhibited faint feelings shortly after receiving the HPV vaccine. This nurse was unable to obtain manual blood pressure reading; client reported that her blood pressure usually runs low. Another nurse called supervisor who arrived shortly with emergency tem members.  EMS was notified as well. Supervisor,  emergency team, and security arrived and automatic blood pressure reading in the upper systolic 90's was obtained. The client appeared nauseated but was still responsive. By the time EMS arrived, client's condition appeared less pale and blood pressure reading improved. Client expressed she felt better,  declined care from EMS, and ambulated out of the area with mother.
Days following the first shot patient has been experiencing multiple nose bleeds a day - all time of the day and night. For that reason she did not receive the 2nd shot.  Also, she went to a check-up in May with a healthy record (age 91 and NO medications). She went for another check-up in August and her doctor discovered she now has A-Fib.
Rash first appeared on forehead then generalized; fever 101F, chills, cervical adenopathy;
Around 10am patient claimed to be dizzy, nauseous. She "passed out" momentarily and vomited. Pt was observed while pharmacy staff called 911. We did take pulse and BP, both were normal. Pharmacist took her to hospital, time was around 11am.
After few minutes of getting the vaccine, patient fainted for couple of seconds while sitting on the chair. Patient regained consciousness right away and was place on the floor lying down with legs raised. Paramedics were called to check on the patient. While waiting for the paramedics, was asked if he has any chronic conditions or had any breakfast in the morning prior to getting the vaccination. Pulse was checked and was 90 bpm. After couple minutes of lying down was moved to a chair to sit. He appeared to be shaking and nervous. Paramedics came and checked his glucose, blood pressure, pulse and asked few questions before clearing him. Patient refused to go to the hospital and sat down for 10-15 minutes before returning to his home.
Headache, chills, body aches, fever of 101.2.  Lasted until about 08:00 PM.
I felt like racing in chest and had little red spots around chest area(appearance ringworms 40-50 in count).
no prior resp problem; 6 hrs p/vax progressive bronchospasm to mild cyanosis; oxymeter 88, responded to Decadron;
Information has been received from a registered nurse concerning a 43 year old male with high blood pressure and diabetes and no drug allergies who on 08-SEP-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651321/1036P) (0.5 ml), intramuscularly in the deltoid. Concomitant therapy included COREG, DIOVAN, felodipine, glimepiride and spironolactone. On 10-SEP-2006 the patient experienced pain in the injection arm and joint pain from the deltoid muscle to the rotator cuff that prevented the patient from lifting his arm above his head. There was no initial injection site rash or fever noted. The muscle/joint pain lasted for 2 weeks until the office was contacted. The patient was instructed to take ALEVE two tablets every 12 hours at that point. On 27-SEP-2006 the patient had recovered his full range of motion in the arm and was feeling fine. The nurse stated that the patient's symptoms were not serious. The patient's symptoms "resolved on their own." Additional information is not expected.
Felt dizzy in elevator leaving office, per mom almost fainted. Came upstairs. No syncope or vomiting. Laid down, given juice, observed, did fine.
Narrative:  32 yo male with PMH of headache, carpal tunnel syndrome of R wrist, bilateral hand weakness, and GERD who reported chills, fever, headache, body aches, N/V, diarrhea following Pfizer COVID19 vaccine on 2/18/2021 (via triage line). Patient was advised to use Tylenol or ibuprofen OTC as needed for  above symptoms. Patient received COVID19 vaccine (first dose) on 2/15/2021.  Vaccine was administered without complications. The patient denied any prior  severe reaction to this vaccine or its components or a severe allergic reaction such  as anaphylaxis to any vaccine or to any injectable therapy.
Information has been received from a 20 year old female with an allergy to Zomig and a history of multiple miscarriages. On 11-JAN-2007 the patient was vaccinated with her first dose of Gardasil when she was 4 and a half weeks pregnant. The patient took a urine Human chorionic gonadotropin (HCG) test in the doctor's office that said she was not pregnant, and they administered the vaccination on day. On 17-JAN-2007 the patient discovered she was pregnant. On 21-JAN-2007 she had a miscarriage. Medical attention was sought. Her outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Additional information has been requested.
Sicker the day after the second shot then when I actually had Covid in September of 2020. Bad joint pain, nausea, headache and fatigue. Could not go to work.
Allergic reaction to VZV given 5-6-13 red rash, swelling 4mmx4.5 min, hot to touch, painful to touch.
Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1 ear, but no fever or redness or pain in ears. No other infections or symptoms thereof. ER visit with blood and urine tests and an MRI revealed nothing definitive. Response to symptom-alleviating shots was less than desirable, hence the MRI. Sent home with anti-vertigo and anti-nausea prescriptions and referral to an ENT specialist (appt set for Mar 21). Patient unable to do anything but lie down. Efficacy of prescriptions is pending. Symptoms are projected to gradually subside and eventually disappear.
I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minutes I was allowed to leave. When I left I only had a slight headache, but nothing that seemed very noticeable. I felt a tad woozy but it was nothing serious so I went on with my day and went to my sports practice for an hour and a half. After I got home and had eaten, I was working and started to feel the effects. It started with an increasingly worse headache at around 9 and as the night went on it got worse and I constantly needed to lie down. My arm had started to feel sore but it was nothing much. I thought I could sleep it off but woke up feeling horrible. My stomach could not hold any food down and my headache had become really bad. I had to go to my sports game but on the car ride over (around 45 min) I got very nauseous. Throughout the course of the day my headache would get worse any time I tried to run and all I wanted to do was lie down and sleep. I was barely able to stand, let alone run and I felt sleepy all day. My arm had also gotten very sore and any contact on it made me flinch back. I was not able to eat or drink anything until about 4  in the afternoon and my stomach was not sitting right the entire time and I constantly was burping and feeling like I was going to vomit despite having only water in my stomach. After I was able to eat the stomach ache went away a bit but the headache lasted through the night and has finally started to subside two days later.
Headache, tachycardia (130 pulse ) nausea, vomiting. Light headedness
Information has been received from a registered nurse concerning a 5 year old female with no pertinent medical history and no known drug allergies who on 27-JAN-1999 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (subcutaneous injection, lot # 628147/1262H).  There was no concomitant medication.  The nurse was reporting that on 05-FEB-1999 the patient developed itchy rash on face, ears, nose, and hands after receiving her first dose of VARIVAX (Merck).  On approximately 01-SEP-2009, the patient had the titer done, but it came back as negative for varicella immunity.  On unspecified date, the patient recovered.  On unspecified date, the patient saw the physician.  Follow up information has been received from a healthcare professional indicated that a 6 year old (previously reported as 5 year old) patient experienced rash on 27-JAN-1999 (previously reported as 05-FEB-1999).  Additional information is not expected.
Arm soreness; Light headed; Nausea; Fever; Chills; Vomiting; Headache; Neck pain; Lower back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting), HEADACHE (Headache), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain). On 13-Jan-2021, LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), CHILLS (Chills) and VOMITING (Vomiting) had resolved, HEADACHE (Headache) was resolving. At the time of the report, NAUSEA (Nausea) had resolved and PYREXIA (Fever), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was unknown.   Reporter did not allow further contact
Immediate negative taste in the mouth Within 2 minutes pounding searing headache lasted 6+ weeks Within 15 minutes heart started to flutter and lasted 5 days  Same night rash on torso and neck. Lasted 3 weeks Same night urinary burning started. Constant for 3 weeks (all tests came back neg) and now is intermittent  Severe lethargy - was unable to function for 2 weeks   Now confirmed I experienced a heart attack and have heart issues that I did not have 4 months ago or 1 year ago (EKG confirmed)
arm sore; This is a spontaneous report from a sponsored program . A contactable female consumer (patient) of an unspecified age received BNT162B2 (Pfizer Covid 19 Vaccine, Solution for injection) via an unspecified route of administration on 21Jan2021 at single dose for Covid 19 Vaccine. Patient medical history and concomitant medications were not reported. Consumer Had her 1st dose of Covid 19 Vaccine on the 21Jan2021 and had a little arm sore after the vaccine but it was fine now on an unspecified date in 2021. Was it Okay to have a weekly/hourly allergy shot? Before/after taking the covid 19 Vaccine. Cold transfer to another unit due to longer than normal wait time. Outcome of event was recovered on an unspecified date in 2021.  Information on the Lot/batch number has been requested.
This spontaneous report as received from nurse practitioner via company representative refers to a patient of unknown age. No information regarding current condition, medical history or drug allergies were reported. On 10-APR-2015 the patient was vaccinated with ROTATEQ suspension 2 (strength, dose, lot number, expiry date and indication unknown) oral. No concomitant therapy was reported. On 10-APR-2015, patient immediately spit up or vomited after administration of a dose of ROTATEQ. The patient was in office and neither treatment nor laboratory test were performed. The patient was administered another dose of ROTATEQ at that same office visit. The outcome of event was reported as recovered/resolved on same day. The causality of event to ROTATEQ was unknown. No further information provided. Additional information is not expected.
Minor hives began around body- bug bit sized, coming and going within an hour. Arms and upper torso (6 days after vaccine) Swollen "Covid arm" rash and firmness at injection site (8 days after vaccine)  Minor concerns- just reporting for record keeping purposes.
My child received the Hep A, MMR, and varicella vaccines on 4/14/22. She spiked a 104 fever in night/morning of 4/18/22 and had a febrile seizure.
Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself).  A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2¸ (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: EL9264, Expiration date: Unknown) as 1st dose, single dose for COVID-19 immunisation. There were no known allergies. Medical history included COVID-19 from Nov2020 to an unknown date, bipolar disorder from an unknown date. Concomitant medication included duloxetine (DULOXETINE, 60mg daily) taken for an unspecified indication, start and stop date were not reported, lamotrigine (LAMOTRIGINE, 100mg daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID was not tested post vaccination. On 01Feb2021 07:00, the patient experienced swollen lymph nodes in armpit of arm where injection was put, tender to touch. Therapeutic measures were not taken as result of events. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 18:34, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
VAQTA was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported.      On 30-NOV-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) which was after a temperature excursion (0.5 milliliter, lot # T031202, expiration date 14-JUN-2022, route was not reported) for prophylaxis (Product storage error).    Administered dose of vaccine experienced the temperature excursion of 14.1 degrees Celsius  for 14 hours. There were no previous excursions.  This is one of the two reports from the same reporter.
Sore arms; Sore shoulders; Fatigue; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Feb2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included acromegaly. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On an unknown date in Dec2020, the patient underwent SARS-COV-2 test (saliva test) and the result was negative. On 24Feb2021, the patient experienced sore arms and shoulders, fatigue and runny nose. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arms, sore shoulders, fatigue and runny nose were recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Reporter first name and last name.
was given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 7th September 2021, the patient received Menveo. On 7th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The reporter stated that, the patient was given an expired dose of Menveo on 7th September 2021. The Menveo expired on 31st August 2021,Which led to expired vaccine used. The reporter consented to follow up. The initial and followup processed together.
mom states tired p/IPV 14SEP93 fever in AM; 15SEP93 mom gave APAP; no temp taken doesn't own thermometer; 15SEP93 mom states pt passed out & couldn't breathe;
Very sore upper arm. Could not touch site. Could not straighten, raise or move arm for 48+ hours after injection. Still sore to touch day 7. Very fatigued, no energy for 24 hours. Felt like I was getting sick.
woke up at 3 am 1/3/21 with flu like symptoms: chills, fever, body aches, weakness and headache which lasted all day. woke up 1/4/21 feeling better but had headache and was very weak. 1/5/21 still very weak but headache gone