chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shipment had been in transit to long with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist. (Reference number-00325689) and transmitted to Sanofi on 21-Oct-2020.    It was reported that a 68-year old patient (gender not reported) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT (lot number: UJ546AA, expiry date: 06/30/2021, Route: Via intramuscular in the right arm) which received delay shipment (Product distribution issue) on 19-oct-2020 and vaccine will administrated as soon as they received for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product shipment delay.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was hospitalized on 1/14/22 for resp. failure due to COVID.  patient remains hospitalized today, 1/17/22.  Patient has had 3 doses of COVID Pfizer vaccine on 12/28/21, 5/24/21 and 5/3/21
pt recvd vax & had t 99-100, by Sunday, fever was 102.8; tx w/ apap & ice packs; by tues fever was gone; pt c/o severe muscles aches & pains;
Caller states she received her 1st Pfizer vaccines yesterday around 4:30 PM. The caller is 7 months pregnant. She states she has a 100.5 temp, muscles aches and fatigue.  Encouraged to call OB/GYN  MD to see if it is approved for her to take Tylenol for temp and aches and pain. Also encouraged to increase fluid intake, rest and recheck temp in 2 hours and to notify MD if fever remains elevated.
C/o distended bowel, refusal of breastfeeding and issues with stooling for 3+ weeks following Rotavirus vaccination.
Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 14:30 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for Covid-19 since the vaccination. Medical history included Anxiety, depression and known allergies: Tree nuts. Concomitant medication included duloxetine (DULOXETINE), mirtazapine (MIRTAZAPINE), lamotrigine (LAMICTAL) and gabapentin (GABAPENTIN) all taken for unspecified indications, start and stop dates were not reported. The patient experienced bells palsy on 24Apr2021 at 19:00. Therapeutic measures were taken as a result of bell's palsy which included Prednisone and Valyacyclovir. The patient received first dose of BNT162B2 on 29Mar2021 (lot ER8730) at 15:30 administered to right arm. Outcome of the event was recovering.    Follow up attempts needed. Further information is expected
Patient received the Pfizer COVID-19 vaccine on 1/12/21 and 2/1/21, so was fully vaccinated when they tested positive on 8/20/21.
Pruritic rashes all over the body about 7 hours prior to consultation ( today is 3/3/2003 ). Presence of rash on the extremities (upper and lower) and trunk. Smallpox vaccine given on 2/22/2003. Treated by Dr. with Sarna Topical Lotion to be applied as needed. Oral antihistamine given at the ER this AM.
bed ridden for 7 days, er visit-major surgery for blood clots-aorta and leg, rehab for 3 weeks
Headache; Muscle pain; FEVER; chills; joint pain; Belly pain; Felt nauseas; Runny nose; Cough; Bruise on injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 79-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 was provided by reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE INJURY (Bruise on injection site). On 26-Jan-2021, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Cough). On 27-Jan-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas). At the time of the report, INJECTION SITE INJURY (Bruise on injection site), RHINORRHOEA (Runny nose), COUGH (Cough), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (FEVER), CHILLS (chills), ARTHRALGIA (joint pain), ABDOMINAL PAIN (Belly pain) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: process together
The vaccine was processed under a file belonging  to a patient that was 65 + who happened to have the same having the same first and last name.  We discovered the error 2 days later when insurance alerted us of duplicate payment.  I have left voice mail for the patient and her spouse.
discomfort in the throat; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; face and eyes became swollen and itchy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Face and eyes felt hot and was painful to touch as well as rashy; Neck started to feel itchy.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular in left arm on 21Dec2020 07:45 AM at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 21Dec2020 08:00 AM, the patient experienced a discomfort in the throat, then face and eyes became swollen and itchy. Face and eyes felt hot and was painful to touch as well as rashy. Next morning, face and eyes remain swollen but not painful to touch. Neck started to feel itchy. The events were reported as non-serious. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of  the events which included BENADRYL. The outcome of the events at the time of last observation was not recovered.
Patient woke up day after vaccination with chickenpox-like spots all over her legs, said they itched prettty bad, and reminded her of chicken pox. She stated she felt otherwise fine, no fever, etc.  She said she was putting an "itch cream" on her legs. I counseled her to keep an eye on the spots, use cortisone cream/benadryl, and to let me or her doctor know if it worsens.
This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, left arm, on Mar 6, 2021, single dose, for COVID-19 immunisation. Medical history included penicillin allergy. The patient has not received any concomitant medication. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On Mar 22, 2021, patient experienced muscle twitching and weakness. On May 25, 2021, patient underwent COVID-19 test, which included nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the muscle twitching and weakness: not recovered (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained.
horrible,pounding headaches, my head was going to blow off; get sick from the headaches; couldn't do anything for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pounding in head in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pounding in head, sickness and activities of daily living impaired. On an unknown date, the outcome of the pounding in head and sickness were not recovered/not resolved and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the pounding in head, sickness and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Had the shingles shot that patient's head was going to blow off could not do anything for 3 days cause of the horrible, pounding headaches. Now if patient did not take something for them every 3 or sooner hours, patient literally get sick from the headaches.  The reporter asked the pharmacy guy he said people usually get the flu or were just plain sick, couldn't understand about his/her headaches. No more of them shots for him/her. Additional supportive information: Follow-up would not possible as no contact details were available. This case has been linked to the case US2022AMR076751 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076751:same reporter
Nine minutes following vaccination, patient complained of dizziness (8/10) and weakness (4/10) and was escorted to gurney to lie back. BP=138/84, HR=84, RR=16. Patient also complained of left arm weakness radiating to 5th finger while seated; diaphoretic, nauseated. Clinic staff administered liquid benadryl 40mL/100mg PO.  Patient symptoms resolved at 10:25am and released to home.
Got sick; Weakness; Sweatiness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting). At the time of the report, ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Vertigo and dizziness (which I?ve never experienced before) began this morning and can think of no other probable explanation, thought I?d share.
rash at injection site day after injection that subsequently spread and now has red, blotchy, itchy rash covering entire body. treated with steroids and antihistamines
On 5/11/2021 when I received the second dose, my arm started to hurt. It was hurting really bad. I could not lift my arm above my shoulder without pain. From then, I was really tired and I had to sleep. When I woke up the next day I had a fever. For the next 5 days after receiving the vaccine I kept having the fever. My highest temperature was 103. I was tired all those days. It was hard to do any regular activities. I worked from my couch and when I had to work I had to take it easy. I could not look at the TV or any video games because I was very nauseated. I ended up having a teladoc visit on 05/16/2021 because my fever was still going on. They prescribed me Ondansetron hydrochloride and I started to feel better. After a week or so I was completely recovered.
Patient stated that she still has a "lump" where she got her flu shots. She stated she was unable to take tylenol or ibuprofen although patient is getting acetaminophen in the Norco that she takes.  Explained that heat or ice may help and if it was not getting better to follow up with her doctor.
Tingling and numbness in both hands.  Hands will be numb when first waking up in the morning.  Swelling in hands, fingers, and forearms.  Difficult making a fist.  pain in both elbows and extreme pain in right shoulder.  Tylenol 500mg
The area where I got the shot started itching. Then it developed a bump that looked like a large mosquito bite. Over the course of 3 hours it swelled into a lump the size of a baseball that was itchy, red, and hot. I put ice on it and the swelling went down overnight. It proceeded to get hot and itchy the next day and I went to urgent care. The redness preceded to spread in a diagonal area toward my bicep and got better over the next 4 days with ice.
Pt had Tdap 5/6/2011. Developed severe dizziness 48 hrs later. Went to ED. Stated ED physician thought it could've been related.
Significant swelling, redness, pain at site of injection; Swelling became progressively worse to involve entire upper arm from shoulder to elbow.
Burning/hot sensation all over the body especially when in bed, she gets up out of bed and starts walking around.
Constant headache except when he sleeps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Jul2021 (Lot number: EW0180) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, single, lot: EW0178, location: arm), administration date: 14Jun2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset Sep2021, outcome "unknown", described as "Constant headache except when he sleeps". The event "constant headache except when he sleeps" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache. Clinical course included the patient had been experiencing constant headaches after receiving both doses of the Pfizer Covid vaccine, the mother mentioned that her son had been given IV Toradol, Motrin, Excedrin, Zyrtec allergy medicine, Flonase and another other allergy spray that did not decrease the headaches. The patient had been to the emergency room 2 times, and he had seen his PCP, back and forth, he had been to ID, and nothing. The headache required a visit to Emergency Room and Physician Office (he had been to the primary care and they were trying to get him an appointment with a neurologist).
Evening of vaccine got arrhythmia  (bigeminy)  for about an hour.  Drank Coke with aspirin and it stopped.  3 days later my feet turned purple for about 5 hours gradually mottling and going away Both these never before or since  Sore left upper arm still at 2 months.  At first couldn't raise arm above head and extreme pain now only slight pain if roll over in sleep or rubbed.
pt recv vax & devel hives on the face;nothing on the arm where had shot;no other med are taken except BCPs;took ASA 3 days ago;has had no chemical exposures;apparent urticaria rxn to hep b vax;feels warm & c/o lt side face & lip tingling;
**************COVID BREAKTHROUGH CASE**********************   Working the election all day On Tues I checked in everyone in my precinct. I was the only one wearing a mask from 6:30am -6:30pm. I also helped set up the event as well. I always wear my mask and I always and my husband works from home. I have no clue where I could?ve been exposed because I am very careful. I got tested on Friday at the CVS Minute Clinic. Stuffed up but in my head -congestion weird headaches  weight loss  no fever but i felt hot I did a home test and it was positive  I waited 3 days to get tested and it was positive. I called my PCP and they weren't helpful at all. I found a clinic near me and got Paxlovid
fine lacy rash on face, neck, trunk of body w/c/o itching using calamine lotion PNR for itching;
p/30 hr pt got the flu started w/ scratchy throat, then aches, fever, sore throat, sinus infect, laryngitis;
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.            Concomitant medications were not provided. Patient stated that at the moment of she was experiencing an urinary tract infection. Treatment information included Antibiotics.
Within several days of receiving the Moderna booster I experienced  occasional diarrhea which continually got worse.  As of the date of this report I have had diarrhea 9-10 times daily for 4 continuous months.  Colonoscopy was normal in January 2022 thinking that might be a reaso n for the diarrhea but it isn?t.  Numerous prescriptions from primary care physician have been totally ineffective.  * I have had perfect digestive system until getting vaccinated. The booster shot started this nightmare medical condition. I can only hope the booster wanes quickly- will never again trust the science behind a rushed vaccine.
for 48hrs p/vax pt had intermittent spells of paleness w/sudden deep sleep & difficulty arousing
Twitching below right eye on right cheek; This is a spontaneous report from a contactable consumer, the patient. A 51 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Batch/lot Number: EN6200) via an unspecified route of administration on left arm as single dose on 02Mar2021 at 19:30 (at the age of 51-years-old) for COVID-19 immunization. The patient's medical history included chronic migraine, twitching on eye and Gastroesophageal reflux disease (GERD). The patient previously took penicillin, codeine and Diflucan, and developed allergy to all the three drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications include Famvir, Celebrex, Wellbutrin, atenolol, and Emgality. On 03Mar2021, the patient experienced twitching below right eye on right cheek, which would come and go. The patient felt like she was having a transcutaneous electrical nerve stimulation (TENS) unit on her face. The patient also felt it was very different to a twitch she would get on her eye. The patient did not receive any treatment for the event. The event twitching below right eye on right cheek was not resolved. No follow-up attempts are needed. No further information is expected.
After 24 hours I start having fever, all night I had a fever on April 18th. I had a fever in the past and nothing was abnormal about this. On 19th started something I can not explain and never felt anything like this before. I felt dizzy, nausea, fever without a temperature, felt overheated, hard to breathe. It felt like I am on drugs to the point I could put clothes on and was feeling like I am passing out. I could think or talk or anything. My boyfriend drove me to the ER but unfortunately all they could say it is the side effects after the vaccine..Nothing helped, I was dizzy and felt like my heart will stop any second... Today is April 24, I feel better however feeling of nausea, headache, and a foggy mind is coming back in the different moments. I noticed that my ears and throat are still burning but I don't feel sick, it is something else. I tried to go out for lunch but couldn't spend there even an hour, the feeling coming back, I can't focus and the noise bothers me... I used to be a completely healthy person. I afraid nothing will help me. I would like to report these cruel side effects.
Pt returned to pharmacy on 7/29 complaining of injection site redness, itching, warmth on left arm (appeared a little swollen compared to opposite arm).  No report of trouble breathing.  Recommended ice pack, and antihistamines.
slight pain in arm due to covid vaccine; This is a spontaneous report from a contactable consumer or other non HCP. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA, Batch/Lot number was not reported) via oral from 08Jan2021 and ongoing, at 14 mg, daily for thyroid cancer. Patient stopped taking Lenvima- 21Mar2021- 28Mar2021, to have a break from side effects, dry mouth wakes him up at night, certain liquids/foods burning tongue,", all resolved after patient stopped Lenvima. MD aware of missed doses. No side effects due to missed doses.  Medical history included arthralgia from an unknown date and unknown if ongoing has improved since MD added Percocet. The patient's concomitant medications were not reported. The patient experienced slight pain in arm due to covid vaccine. The patient underwent lab tests and procedures which included positron emission tomogram: everything is smaller, even the lump in your throat on. Since starting Lenvima- Recent positron emission test showed "everything is smaller, even the lump in your throat". The outcome of event was not recovered/not resolved.
Intense burning sensation just below rotator cuff.  Severe soreness at injection site for about 3 weeks.  Thereafter, muscle weakness and intense soreness when lifting arm, effectively limiting motion.