chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious initial spontaneous case, was received from a Pharmacist on 06-Sep-2017, concerning a 53-year-old adult male patient. The patient's medical history included work injury (years ago) but was not sure of the extent of it. The patient's current conditions included sleep and prostate related disorder (since an unspecified date). The patient concomitant medications included trazodone (sleep) and tamsulosin (for prostate). On 27-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, lot number: 195214, expiry date: Apr-2018, route of administration, anatomical location: not reported). On the same day, after vaccine administration, the patient's arm was quite sore from the shot. He felt his arms heavy and sore. On 28-Aug-2017(the day after the shot), he got hives all over his body. It was reported that the hives were kind of sporadic, randomly present all over and they had not gone yet. Hives got better once but moved to a different place. The patient's sore arm persisted for 10 days from the administration of vaccine. The patient was treated with prednisone 10 mg dose packs for 6 days. The patient was not hospitalized for the events. At the time of this report, the patient was not yet recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 19-Oct-2017: The patient's concomitant and treatment medications were updated. Narrative amended accordingly.
My left arm shoulder front and back are hurt. Also my check hurt and I'm kind of run out of breath.
On 07/17/2022, I developed terrible chills. Monday, I woke up coughing as well as still having the chills. Tuesday, I woke up with the most horrendous sore throat I had ever had. I also noticed a decrease in my sense of smell and taste, so I went to see my doctor. He prescribed an antibiotic and advised that I begin taking that while I was waiting on my COVID-19 test results. He stated that if my test was positive, I would need to stop taking the antibiotic and begin taking Paxlovid. He called me that next morning with positive results, and I began taking the Paxlovid later that day. The Paxlovid left a terrible taste in my mouth and for 3 weeks after ending the medication, I still could not taste or smell anything. I still, on 11/04/2022, feel as though my senses have not returned properly. Food does not taste or smell right to me.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # R006466, expiration date: 24-OCT-2019, dose and route of administration were not provided) for prophylaxis. Administered dose of PNEUMOVAX 23 experienced multiple temperature excursion between 47 to 77 Fahrenheit degrees (reported also as 49.1 Fahrenheit degrees) for 40 hours and 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1812USA006579.
Pt recvd 1st dose of Engerix-B 17APR91; On 19APR91 pt exp flu-like sx; pt seen in ER;
12/27/21 presents to ED for "low blood pressure and sinus infection". PMHx of "hypertension diabetes ESRD on hemodialysis"
1.  Metallic taste immediately after receiving shot. 2.  Large red welt about 1/2 inch beneath injection site noticed it within an hour; itchy and grew to about the 1 1/2" in diameter.  By day three post injection, it has diminished by 90%. 3.  Approximately 20 minutes after injection, face and lips became numb predominantly on the right side.  Similar feeling to when one receives novocaine.  Could  not see any visible swelling.  This peaked about 1 hour after shot and was gone about 4-5 hours after shot.
Pt complained of tenderness in the left side of her neck and upper back after receiving the flu shot.
-2 hours after injection of booster, Experienced sudden onset tachycardia with HR or 130-140 lasting for approx 30-40 min after injection time.  Experienced shortness of breath and mild chest discomfort.  Blood pressure at this time was 140-90's, much higher than normal.  Was advised by Nurse consult to be evaluated.  While waiting in Urgent Care, tachycardia suddenly resolved to HR of 80-90's.  Felt extreme fatigue afterwards.
Flu vaccine given 9/20/14 pt called on 9/21/14 said there was red circle at site of injection and it was feverish to touch. Advise she go to clinic immediately.
Mild diarrhea; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Benign hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Chronic idiopathic urticaria" (unspecified if ongoing); "Painful hives" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1), administration date: 2021, for COVID-19 immunization, reaction(s): "Seemed to be clear of a chronic condition she had suffered with for 8 years". The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Mild diarrhea".  Additional Information: The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. No other vaccine was administered in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366861
Patient reported redness and swelling at the injection site for 3 days after administration. Patient did not seek treatment. Issue resolved on its own.
Patient administered Moderna COVID-19 vaccine at 12 days instead of 28 days.
Fever 100.5-102, severe headaches, severe injection site pain, severe/complete nasal congestion/blockage-mouth breathing, severe unrelenting cough,  burning in nasal passage, throat/chest, severe pain &  soar throat, throbbing in all sinuses, generalized weakness and general feeling of unwell, loss of taste, loss of smell, loss or heard of hearing, persistent nasal dripping, sneezing,-> light yellow sputum/nasal discharge beginning in week two. Last fever was on 6/21, current persistent symptoms are loss of smell, taste, and partil hearing. Tylenol 500 mg  / ibuprofen every 6 hours x 8 days, Alka seltzer cough /cold x 4 days every 6 hours, Sudafed every 6 hours x 4 days, Benadryl 25 mgs every  4- 8hrs x 5 days, Amoxicillin 500 mg twice daily x 15 days
Medication Administration Error. Patient received 0.25 mL of Moderna bivalent vaccine instead of 0.5 mL on 9/19/2022.  The patient was contacted later in the day to notify of error and returned to clinic on 9/21/2022 for an additional 0.25 mL for a full dose.
This was a 3rd shot / booster  I developed painful raised white bumps on the tip of my tongue and a couple of bumps on inside of lips --- I would doubt this is serious but wanted to report it. As of 10/19/2021 I still have painful bumps on tip of tongue but on the right instead of left side
None. Pt was erroneously given a Hep B injection when he was supposed to get a Tdap.
Planning for second dose of vaccine past 42 days from  the first; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Planning for second dose of vaccine past 42 days from  the first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Back surgery.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced OFF LABEL USE (Planning for second dose of vaccine past 42 days from  the first). At the time of the report, OFF LABEL USE (Planning for second dose of vaccine past 42 days from  the first) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Because of the back surgery, the health care provider of the patient did not recommend second dose on time.
Sporadic severe pain at injection site x 3mos.Pain relieved with Aleve tabs 2.
In February 2023 I had a lot of bloating, pain and constipation.  I took a lot of Gas-X and MiraLAX.  In mid-March my gut nearly shut down.  I had constant constipation and pain.  I went to urgent care end of March and early April.  I saw my doctor end of March and a gastroenterologist.  I am now on antibiotics and anti-cramping medicine.  We are monitoring everything to see what a final diagnosis.  I see her again in about 3 weeks.
I was very sore at the site of injection around 6-7 PM. At approximately 1:00 AM, I started experiencing a fever (101.3 F), chills, aches, and some heart palpitations. I took 1000 mg of acetaminophen, which helped to reduce the fever and chills.  When I woke up, I was nauseous, had a serious headache, fatigue, minor chills, a fever (101.3 F) and more noticeable heart palpitations (when measured with my smartwatch, it reported bpm of 118-124). I had a virtual consult with a physician who advised me to be seen by urgent care immediately.
patient received the 2nd dose of vaccine and when waiting after administration, patient experienced a seizure; This is a spontaneous report from a contactable pharmacist. A 20-year-old female patient received bnt162b2, intramuscular on 02Jun2021 14:00 (Lot Number: ER8730), at the age of 20-years-old, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Apr2021 (lot number: EW0153), at the age of 20 years-old, for COVID-19 immunisation. The patient received the 2nd dose of vaccine and when waiting after administration, patient experienced a seizure on 02Jun2021 14:00. Ae resulted in Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. No treatment received for the event. Unknown if covid prior vaccination and unknown if covid tested post vaccination. It was unknown if the patient received other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Seizure due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. 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.
I had cramps and pinched nerves all around heart area. Inflammated heart with symptoms of congestive heart failure.  Felt tired after workouts, heart was beating too fast at maximum heart rate. Heart started beating out of rhythm during a long hike. Rest and non-red meat diet with advil was taken for heart inflammation.  Advil reduced inflammation and took 3 weeks of advil 5 days a week at 200mg. No doctors help was given.
2 weeks after the second dose of Moderna, I started to have nerve issues in my legs and feet. Tingling, sporadic stabbing pains. Went to the neurologist and had a punch biopsy done to confirm it was small fiber neuropathy.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two female patients vaccinated with improperly stored VAQTA (lot# N008823 with expiration date 26-MAY-2018) on 25-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004982).
Breastfeeding newborn (10 days old). Stool was green & mucous-y for 24 hours following vaccine (~3-4 hour delayed onset from vaccine). Baby fussy and irritable when passing stool. Seemingly had more gas.
Pfizer COVID Vaccine FC3180-given 8/6/21 and 9/8/21. New onset torsades de pointes requiring 2 ER visits, 2 hospital stays and AICD placement. New onset orthostatic hypotension requiring pressor medication management. Patient had no prior history of any medical problems, was on no medications, no family history, no pre-existing co-morbidities. Was previously active and exercised daily with no issues. She began to have pre-syncopal and syncopal episodes 2 wk after her second Pfizer shot. Went to the ER and was hospitalized for evaluation. CTA chest, CT brain, ECHO, labs and telemetry monitoring. Continued to have episodes. Event monitor placed. Had a significant episode while wearing the monitor requiring EMS and transportation to ER. Event monitor showed sustained polymorphic ventricular tachycardia. She was admitted to the hospital and AICD was placed. Orthostatic hypotension persisted throughout this even when patient is in sinus rhythm. Requires oral pressor medication to treat this.
pain and discomfort in left shoulder/arm, lack of range of motion was severely limited,  burning, aching and throbbing sensation, the symptoms started  the day after the vaccination and continued 24 hrs a day for weeks.
Redness extending from arm to neck, pain from arm to neck to back. Treatment Decadron 8mg IM.
patient came back to pharmacy to day(10/21/2021) to report adverse reaction he experienced after his vaccination According to Mr, about 1 hour after he the Moderna Covid-19 vaccine, he felt fever, weak, shortness of breath, hives, lost of taste and lost of smell He stated that he got Covid infection again and he already had Covid 3 times in the past He is Ok now but the rash on his wrist is still there. Pharmacist is not sure this rash related to Patient was advised to talk to his health care provider for alternative
Right arm cellulitis at injection site with fever, tachycardia, nausea and vomiting. The hospital discharge summary received on 1/28/04 states wheezing, headache, malaise, tachycardia, rhinitis, chest pain and cough.
pt was given flu vaccine 4 days prior to turning 6 months when it is approved for. No adverse outcome.
"a little sore at the site" after receiving those previous doses; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): ""a little sore at the site" after receiving those previous doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): ""a little sore at the site" after receiving those previous doses". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as ""a little sore at the site" after receiving those previous doses".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient was asked if was pregnant at the time of vaccination and stated she was not pregnant.  She was vaccinated with MMR and Varicella to satisfy immigration requirements.  She subsequently found out she was pregnant and likely was about 3 weeks pregnant at the time of vaccination.  LMP 14 October 2018, has irregular periods and due to fertility issues did not think she could get pregnant.  No symptoms after vaccination, no fever/rash/suspected viremia.  No adverse event noted but VAERS recommended on CDC website due to receipt of Varicella vaccination.
sleepiness; felt like vertigo; Head feeling heavy; 3 itchy red spots near inner right arm; slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Endothelial corneal dystrophy, Squamous cell carcinoma in March 2019, Corneal transplant (Right eye) since October 2018 and Cataract operation (Left eye) since November 2019. Concurrent medical conditions included Vertigo, Benign positional vertigo, Coronary artery disease, Tinnitus, Chronic idiopathic constipation, Osteoarthritis, Osteopenia, Osteoporosis, Hypothyroidism, Anxiety, Lichen sclerosis atrophicus, Gluten sensitivity, Allergy (Lactose intolerance), Drug allergy (Aspirin), Drug allergy (Ibuprofen) and Drug allergy (Sertraline (Zoloft)). Concomitant products included ALPRAZOLAM for Anxiety, DIAZEPAM for Vertigo, LUBIPROSTONE (AMITIZA), LEVOTHYROXINE, ROSUVASTATIN from 20-Nov-2020 to an unknown date, CLOPIDOGREL from 15-Aug-2020 to an unknown date, ESTRADIOL from October 2020 to an unknown date, DIFLUPREDNATE (DUREZOL), LOTEPREDNOL ETABONATE (LOTEMAX), VITAMIN D3, DHEA, MULTIVITAMIN [VITAMINS NOS], CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), DOCUSATE SODIUM (COLACE), MACROGOL 3350 (MIRALAX), MAGNESIUM and BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM BREVE, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PRIMADOPHILUS BIFIDUS) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-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 SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea). The patient was treated with DIAZEPAM (VALIUM) for Vertigo, at a dose of 1 mg. On 09-May-2021, SOMNOLENCE (sleepiness), VERTIGO (felt like vertigo), HEAD DISCOMFORT (Head feeling heavy), RASH (3 itchy red spots near inner right arm) and NAUSEA (slight nausea) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to  (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: All event outcomes updated and start date and stop date is also provided.
Pt had fever of 104.6F, 3-4 hours, post vax.
Initial unsolicited report received from a pharmacist via other company (Merck) on 05-MAY-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer unknown, dose, batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed Bell's palsy. Patient's lab data and corrective treatment were not reported. The event outcome was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event [Bell's palsy]. List of documents held by sender: none.; Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset is unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, name of vaccine administered, time to onset and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
After patient's wait time post vaccine, he passed out in the parking lot.  Ambulance was called and taken to hospital where he came to.  Stated that his blood sugar was extremely low, in the 20s.  Was in the hospital for 4-5 days because they could not get his sugar under control.