chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Pain; Redness (large wheel); Swelling in her right arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Bexsero .5 ml and MENACTRA. In August 2019, less than a week after receiving Bexsero, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in right deltoid muscle and also received Menactra in her left arm at the same visit. The reporter stated that, the patient experienced severe pain, redness (large wheel), and swelling in her right arm.
Rash and fever for 3 days after receiving shots, 1 week earlier. Seen in ER X 1 and then by pediatrician.
2 days p/vax mom reported swelling to site of DTP-size of an oragne; advised ice to site/cool compresses & oral DPH;
Severe Headache, vomiting,  severe diarrhea, muscle aches, fever 101,  sinus issues, severe sore arm, sharp pains in body
8 hrs after 1st influenza vaccine (TIV) pt developed fever >103 (rectal), headache, tight/heavy breathing. One dose of 400mg ibuprofen was given. She vomited next morning (approximately 18 hours after shot). Febrile still at 24 hours. No local reaction.
Pt was inadvertently given the monovalent vaccine. He is scheduled to return to obtain the bivalent. No reaction to monovalent given.
Different feeling every day; Muscle weakness on my left side, includes the face; Night sweats; Chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 14Jan2021 at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, degenerative disc disease (DDD), anxiety, plantar fasciitis and gastroesophageal reflux disease (GERD). The patient had allergic to statins. 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 vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) for an unknown indication. On 05Feb2021 at 09:00, the patient experienced muscle weakness on left side, included the face. Muscle that was starting on bottom of right foot. The patient had seen gentleman describing this on the news and realized he was having the same symptoms that the patient had. The patient experienced night sweats, chills and different feeling every day. Doctor informed and the patient would be going to neurologist and pain management. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle weakness, night sweats, chills and different feeling was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
gave vaccine Subcutaneously instead of IM, patient is fine, just gave by wrong route
Small blisters (15-20) on various areas of the body face, L finger, abd, legs, L ankle. Started 3 days after injection. Severe itching at sites. No pain. Injection site was sore for 3-4 days, but no visible signs of reaction. New areas still breaking out 6 days out from immunization.
Patient presented to the office 2 days after injection with arm pain, headache, fatigue, fever/chills, and upset stomach. She was also lightheaded and found to be hypotensive with BP 93/50. She received 1 liter NS in the office and BP increased to 108/62 and asymptomatic.
Swelling on the arms; Swelling on the breast; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received HAV (Havrix) (batch number E9G4E, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced swelling arm and breast swelling. On an unknown date, the outcome of the swelling arm and breast swelling were unknown.   It was unknown if the reporter considered the swelling arm and breast swelling to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Havrix and experienced swelling in the arms and breast. The reporter provided all patient identifiers and batch number but no expiration date, as it was not available.
Flu vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
foggy; forgetful; significantly heavier, longer, more painful periods; significantly heavier, longer, more painful periods; Cystic acne; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administration date 14May2021 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 04Apr2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "significantly heavier, longer, more painful periods", "significantly heavier, longer, more painful periods", "Cystic acne". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "significantly heavier, longer, more painful periods"; ACNE CYSTIC (non-serious) with onset 2021, outcome "unknown", described as "Cystic acne"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "unknown", described as "foggy"; MEMORY IMPAIRMENT (non-serious) with onset May2021, outcome "unknown", described as "forgetful". Therapeutic measures were taken as a result of heavy menstrual bleeding, dysmenorrhoea, acne cystic, feeling abnormal, memory impairment.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient did not have COVID prior vaccination and since the vaccination patient was not tested for COVID. Device Date : 06Dec2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
There were not adverse events at the time the shot was administered.  I started displaying symptoms on or around May 10th with tingling in fingertips that I couldn't pin point and joint pain in my left hand below my knuckles (palm side).  Around May 17th, I got swelling in my feet (I took photos) and May 18th, I started to feel itching on the back of my left thigh with no symptoms of a rash.  I woke up on May 19th with what looked like ant bites but by the 20th, I couldn't touch it.  I went to urgent care on May 21st and was diagnosed with shingles.
Patient received booster when not eligible. She is 15 years old. Currently, we are giving boosters for 16 years and up.
The night after this second Moderna shot began to have headache and low grade fever. Had some mild residual myalgia following first shot Moderna Lot 027AA21A on 03/11/21 in left arm but resolved. Overnight began to develop severe morbilloform rash first in buttucks and legs, then posterior chest, then anterior chest, neck. About 80% of body involved. Then after about 30 hours after inject began to have difficulty with esophageal narrowing. Breathing was okay, Speech was okay. Decided to go to Emergency Room at Hospital when I could not swallow my saliva. In the Hospital seen by nurse practioner and ER physician. They started IV line and gave bolus of Dexamethazone 10 mg. Immediately had relief of swelling in esophagus and some improvement in urticaria. They discharged me with orders to take Prednisone 50mg po Qam for three days. I also took Benadril 25-50mg po Q6H to treat pruritus which worked well. By forth day  had 90% resolution of uticaria and pruritus. I had cystic mass develop over right anterior tibial muscle which was red and warm about 5 cm in diameter. This has reduced in size post prednisone. Wearing support stocking and taking Ibuprofen 200mg po BID which as eliminated tenderness and it has shrunken in size. Waiting to see if it resolves or will get ultrasound
INADVERTENTLY VACCINATED BEFORE AGE 12. WRONG PHONE NUMBER, INCOMPLETE ADRESS, COULD NOT BE REACHED
- Mild itching at injection site and over full body within the first hour post vaccination. - overnight (between 5 and 12 hours after vaccination) developed a fever of about 101.5 as well as substantial joint aches and muscle soreness that prevented sleeping.  - About 7 am (14 hours post vaccination,) began to vomit after eating or drinking anything. Vomited several times over the following hours. Tried to follow WHO oral rehydration guidance but even teaspoons of liquid induced vomiting. Substantial exhaustion that prevented leaving bed or going to work.  - Called doctor's office who advised painkilling fever reducers -- tried that but they too induced vomiting. Was advised to wait 24 hours before seeking further care.  - Frequent vomiting subsided on its own around 1 pm (20 hours post vaccination). Was able to eat simple foods and rehydrate that evening, around 24-hour post vaccination, though mild to moderate nausea continued.  - Fever subsided overnight, around 30 hours post-vac nausea and muscle aches continued into second day. Nausea, itching and joint and muscle aches continued into second day and are ongoing.
This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 4 of 5 (see case IDs A0885547A, A0885964A, A0885965A, A0885957A for the other reports).
Narrative: Patient is a 79 YO male admitted 9/15/21 for COVID-19 infection after presenting to the ED with worsening SOB and testing positive. His symptoms began 3 days prior. Of note, he was fully vaccinated. Patient was initially placed on 2L NC after desaturating to high 80s and eventually Oxymask 6L satting 94%. Remdesivir and dexamethasone were started. On 9/16, patient was intubated due to increasing oxygen requirements and inability to breathe without assistance.
patient received two doses of Fluad, first shot on 09/11/2021 and second shot on 10/18/2021. (administration error).
pt recvd vax & exp breakthrough case of chickenpox;no further details were provided;
14x15 cm local reaction inferior to injection site  erythematous, tender, warm, and indurated
On 1/23/21 one week after vaccine administration-itching at injection site, redness (approx. 2 inches in diameter), stiffness in upper arm. Redness is somewhat less today, 1/25, but occasional itching and stiffness still occur.
convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself.   A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30  (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported.  Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Soreness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness on injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-existing disease (pre-existing medical conditions). Concomitant products included DIAZEPAM (VALIUM) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness on injection site). At the time of the report, INJECTION SITE PAIN (Soreness on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   The patient's concomitant medications included gout medications and muscle relaxants. The patient did not received treatment medications and did not suffer any other ill effects from the vaccine.   This case was linked to MOD-2021-062264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Initial Additional-1-Possible NNI
From 8:00 PM last night on patient's had these Symptoms: Low fever, puffy eyes, cough, slight sore throat, loss of appetite. Flu-like symptoms.
she can't move the right side of her face; she can't open her mouth because it hurts; achy all over; weak; felt coming down; fever; earache; a sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (a sore arm), ASTHENIA (felt coming down), PYREXIA (fever), EAR PAIN (earache) and REDUCED FACIAL EXPRESSION (she can't move the right side of her face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). On 11-Apr-2021, the patient experienced ASTHENIA (felt coming down), PYREXIA (fever), EAR PAIN (earache), PAIN (achy all over) and ASTHENIA (weak). On 12-Apr-2021, the patient experienced REDUCED FACIAL EXPRESSION (she can't move the right side of her face) and ORAL PAIN (she can't open her mouth because it hurts). At the time of the report, PAIN IN EXTREMITY (a sore arm), ASTHENIA (felt coming down), PYREXIA (fever), EAR PAIN (earache), REDUCED FACIAL EXPRESSION (she can't move the right side of her face), ORAL PAIN (she can't open her mouth because it hurts), PAIN (achy all over) and ASTHENIA (weak) had not resolved. Not Provided          Treatment: Ibuprofen No concomitant medication was reported .
Patient had significant local reaction with swelling over the entire deltoid area down into arm with errythema, pain and fever. Reported the "whole shoulder ached and was very painful to move." Treatment was supportive care with contrast heat/cold packs and NSAIDS.
6 hrs p/vax t015, an inconsolable cry for 5 hrs; temp responded to Motrin; all fever gone in 24 hrs; 28FEB-PE nl, ears clear; 7MAR-OM
t102 18MAR93; 1PM t103 19MAR93; limp, face flushed; 430PM seen by MD;
Information has been received from a medical assistant concerning a 13 year old female patient with an amoxicillin allergy and no medical history, who on 20-OCT-2006 was vaccinated IM into the upper arm with a first dose of Gardasil (Lot# 653978/0955F). Concomitant therapy included montelukast sodium (MSD) and albuterol. It was reported that the patient got off the recommended dosing schedule because she was sick. On 05-JAN-2007 the patient was diagnosed with pharyngitis (likely viral). The patient was told to take zinc and homeopathic medicine called "INFLAMMATION by Heal." On 08-JAN-2007, laboratory diagnostic studies included a strep test and culture that was negative. On 12-JAN-2007, the patient was seen again and was diagnosed with pharyngitis and a possible ear infection and was given a homeopathic medicine called ("EUPHORIM"), a nasal spray. On 01-FEB-2007 the patient came in for a second dose of the vaccine (lot # 654702/0011U). It was reported that the patient no longer had an infection and subsequently recovered. No product quality complaint was involved. Additional information has been requested.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/24/21 (EN6200) Pfizer Dose 2 3/18/21 (EN6208) COVID Positive 11/3/21  11/3/21: Patient is a 74 year old female with past history of diabetes mellitus, obesity, hyperlipidemia, and hypertension was admitted with 1 week duration of worsening weakness and shortness of breath and found to have COVID-19 pneumonia.  History is obtained from chart review as well as discussion with the patient and the ED provider. Patient's chart notes a history of obstructive sleep apnea although the patient denies and states she does not use a CPAP or BiPAP.  She was admitted in September with lower extremity cellulitis.  She has been vaccinated for COVID-19 earlier this year with to shots.  States she started feeling poorly about 5-6 days ago.  She has had worsening weakness as well as decreased appetite with a loss of taste and smell.  Also had some associated fevers and chills and did have some dry heaving but no current nausea or vomiting.  Also denies any diarrhea.  Continued to worsen and presented to the ER today by EMS.  COVID-19 rapid antigen test was performed which returned positive. D-dimer was elevated and underwent CT chest which did show bilateral pneumonia with no PE.  Currently she is resting comfortably on 3 L of oxygen.  She would like something to eat.  She denies a known history of lung disease and does not use any oxygen at baseline.   11/8/21: The patient is a 74 year old female with obstructive sleep apnea, diabetes mellitus, obesity, hyperlipidemia, and hypertension admitted with 1 week duration of worsening weakness and shortness of breath and found to have COVID-19 pneumonia.  She has been vaccinated for COVID-19 earlier this year with 2- shots.  States she started feeling poorly about 5-6 days before her current admission.  She has had worsening weakness as well as decreased appetite with a loss of taste and smell.  Also had some associated fevers and chills and did have some dry heaving but no current nausea or vomiting.  Also denies any diarrhea.  Continued to worsen and presented to the ER today by EMS.  COVID-19 rapid antigen test was performed which returned positive. D-dimer was elevated and underwent CT chest which did show bilateral pneumonia with no PE.  She was admitted for acute hypoxemic respiratory failure due to COVID-19 infection. Treated with oxygen, levofloxacin, dexamethasone  She continued to have improvement in her oxygen requirement and today she was doing okay on 1 L NC. She will have home oxygen walk and patient will be discharged back on her home medications  She will follow with her primary care provider for further directions
Body aches, chills, head ache, arm swollen and sore, nausea.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided no concomitant medication were reported
a child passed out post administration from GARDASIL 9; This spontaneous report was received from a physician and refers to a child patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly for prophylaxis (strength, dosage, vaccination scheme, anatomical site of injection, lot number, and expiration date were not reported).  On an unknown date, the patient passed out (loss of consciousness) post administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of the event was not reported.  The reporter did not provide a causal relationship between the event and the suspect vaccine.  Upon internal review, the event loss of consciousness was determined to be medically significant.
This is what Mom reported to me on 02-07-2018. On 11-24-2017, the child had a fever of 101 degrees and then had a seizure. They took the child to the emergency room. According to Mom, one of the seizures lasted 45 minutes. Health Center flew the child out to another Hospital. The child stayed at hospital for 3 or 4 nights according to Mom. Mom reports the child was on medication for seizures, but isn't anymore. Mom reports that the child has not had any seizures since this.
pt given 2 doses of DTP (ACTHIB) & devel pertusis; vax given wre suppose to prevent pt from getting pertussis
No additional adverse events; on 5/8/2020 an improperly stored VARIVAX was administered to a patient; Information has been received from a medical assistant referring a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 08-MAY-2020, the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025913, expiration date 20-AUG-2021; dose, strength and route were unknown) for prophylaxis. The sterile diluent that was used to reconstitute the vaccine was properly stored. The vaccine was exposed to temperature excursion between minus 14 degrees Celsius to minus 10 degrees Celsius (minus 11.2 degrees Celsius) for 9 hours and 58 minutes and excursion between minus 9 degrees Celsius to 8 degrees Celsius (3 degrees Celsius) for 13 hours and 35 minutes (incorrect product storage). There was no previous temperature excursion. The call was not due to digital data logger. No additional adverse events were reported.