chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st Moderna vaccine 2/3/2021 adm in left arm  -  Developed soreness the first day, which persisted and became worse 2 weeks following vaccination.  The pain in the left shoulder persists. 2nd dose Moderna 3/3/2021 adm in right arm.   Neck, shoulder and upper arm soreness and pain developed the following day.   He reports significant pain in his neck, and both shoulders at the time of this report on 3/26/2021.  He has not been able to obtain an appt to be evaluated.   He was told by phone that it is a "vaccination reaction and they are not able to deal with it".   He rates his pain 6-10, and causes him to need to lay down at times.    He has called Moderna and was provide a case number.   He was asked for the lot number, but that is not recorded on his vaccination card, and he was not able to get this information from the clinic where he received the vaccine.
Both eyes became very itchy on Saturday January 2.  Sunday morning January 3, my left eye was very red.  Both eyes very dry and itchy.  By noon Sunday, left eye redness gone.  Both eyes itchy.  Monday the 4th, ithcy gone but both eyes very dry.  By Wednesday the 6th all back to normal.  No other symptoms related to vaccination during this period.
Headaches, cycle started  and it should not have, cycle was heavy and abnormal, continues to spot
"Moderna COVID-19 Vaccine EUA" It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021.  It was found during this procedure that pt. had suffered a MI.  She was release to home the following day and passed away at her residence on 1/15/2021.
After receiving vaccine, experienced tingling on both sides of neck, face, lips, eyelids, and cheeks.
Loss of range of motion, pain, swelling, and discomfort. Came from primary provider stating that the shot was probably given too high and into the bursa.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: tetracycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was Unknown. Treatment of COVID-19 with Paxlovid start date: 08Aug2022, stop date: 13Aug2022. Vaccine lot unknown reason was Unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed a circular red, raised rash that initially itched around injection site 6 inches in a oval shape covering outside of arm. Rash is still evident 5 days after start.
FIRST TIME SEIZURE LATER IN SAME DAY FOLLOWING INJECTION 03/16/07-records received from facility for DOS 03/05/07 Seen by PCP with cold like picture, began amoxicillin, and received flu immunization. Expereienced a shaking spell for 5-10 seconds, unresponsive, limp. Seen in ER somnolent and irritable. VS unremarkable. Temp99.  Impression:febrile convulsion or adverse reaction to immunization of flu vaccine. Bronchitis.
Returned to clinic, 3/6/08 with complaint of rash and fever. Hx of spots within 24 hours of vaccination. Spots started resolving 2 days ago. Swollen glands since yesterday and fever last night, 102 degrees. Seen by Dr.--dx tonsillitis, rash, possible epiglottitis, fever, emesis, ?immunization reaction, RAD; referred to ER for evaluation, dx with Acute exudative tonsillitis. Seen in ER 3/8/08, dx viral exanthem.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (exact dose, dose number, lot # and expiration date were not reported, route was reported as "injection"). On an unknown date, the patient had a positive Papanicolaou (PAP smear) test result. The patient did not seek medical attention. It was reported that the therapy with GARDASIL was continued. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as the physician did not wish to be contacted. +
Adverse events: 0600-1030 - Pain in arm got increasingly worse. 1015 -  Felt super cold and nauseous. 1020 - Got a hot flash, felt dizzy and lightheaded, and heard ringing in my left ear. 1025 - I had trouble breathing and my throat felt tight. I developed hives on my forehead, cheeks, neck, chest, and arms. The fingers on both my hands and my lips were tingling.  Treatment: I was rushed to the ER and given an IV steroid, IV fluids (2 bags), and IV benadryl.   Outcome: All the reactions went away within 4 hours and I was discharged from the ER. I was advised to take benadryl for 48 hours afterwards as needed and given a 5 day course of prednisone; 2 tablets taken daily.
Ran fever in evening. Called 911 at 10:30 PM he had a seizure was taking by ambulance to hospital and diagnosed with febrile seizure fur to fever of 103.7 at admitting.
The patient was given varicella vaccine on 5/24/01. The patient developed a fever that lasted from 6/9/01 through 6/11/01. The patient developed a vesicular rash on trunk which started on 6/12/01 and mild pruritus.
Low grade fever (100.1) that did not respond to treatment, body aches, abdominal pain, chest pain, dizziness, weakness, tingling in toes on right foot
bad stomach ache; severe chills; tired; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration in the left arm, on 02Feb2021 19:30, at single dose, for COVID-19 immunization, at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 04Feb2021 at 14:00, the patient had a bad stomachache, severe chills and was tired. No treatment was given for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.
Repetitive behavior including hand-flapping, arm flapping, stiffing arms, hands & upper body, wiggling fingers in front of the eyes.
He has not had an adverse yet, CNP went into the room with the patient and patients father and explained what vaccines were given and possible outcomes given.
Severe lymph node pain and swelling, severe pain and swelling injection site, finger tip numbness and tingling, and joint pain and stiffness in arm where injection given.
severe pain in the kidney on the injection side; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number and Expiration date: unknown), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021, the patient experienced severe pain in the kidney on the injection side. Outcome of event was recovering.   Information lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305789 same reporter/drug/event, different patient;US-PFIZER INC-2021316652 same reporter/drug/event, different patient
Tasted medicine in mouth; Felt weak; Felt like throat was closing; Felt blurry; Hardly could breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Psoriasis (Patient takes the injection for Psoriasis).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSGEUSIA (Tasted medicine in mouth). 02-Feb-2021, the patient experienced ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath). At the time of the report, DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received on 15-JULY-2021 .Event outcome was updated unknown to resolved.
Diaphoretic, pale, blurry vision.   Treatment: Placed in semi-fowlers with feet elevated, water/fluids, deep breathing.   Pt beginning to feel better after 5 minutes of treatment, color improving, talkative, vital signs remained stable.
Fever of 104 for 2 days (normal temperature is 96 degrees F) Severe fatigue, muscle aches, chills Nausea
Patient developed intussusception diagnosed on 10/19. Required surgical resection with loss of some small bowel. Seven day admission.
RN noticed immediate swelling upon giving inject; no other sx, no redness, soreness or pruritis; swelling diminished & gone w/in 36 hrs;
extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; reporter suspects the vaccine was administered too high on the deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
fever up to 102 F, vomiting, headache, myalgias, malaise
My finger is red and purple sore and swollen.; My finger is red and purple sore and swollen.; My finger is red and purple sore and swollen.; Is preganant-Yes,delivery date:05Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Sep2021 16:00 (Lot number: 30130BA) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 01Jun2021. The patient was 15 weeks pregnant at the time of exposure to bnt162b2. The patient was 15 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Mar2022. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Sep2021 14:00, outcome "unknown", described as "Is preganant-Yes,delivery date:05Mar2022"; SKIN DISCOLOURATION (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 29Sep2021 17:00, outcome "not recovered" and all described as "My finger is red and purple sore and swollen.". It was unknown if therapeutic measures were taken as a result of skin discolouration, pain in extremity, peripheral swelling.  Additional information: The patient didn't  receive any other vaccines within 4 weeks prior to the COVID vaccine The patient received Multiple vitamin within 2 weeks of vaccination. The patient wasn't diagnosed with COVID-19, prior to vaccination The patient hasn't been tested for COVID-19, Since the vaccination  No follow-up attempts are possible. No further information is expected.  Follow-up (11Oct2021): This is a Follow up spontaneous report from contactable consumer. This consumer (receptionist) reported in response to HCP telephonic follow up activity which included that: Phone-Out 11:14 PM, 1st attempt by phone to HCP to obtain follow-up information contained on HCP questionnaire. Phone answered by receptionist (No name provided) who provided HCP mailing address.
12/30/21 presents to Surgery for "Vesicovaginal Fistula". PMHx of "hysterectomy and cystostomy repair".
Arm pain started 5 days after getting vaccination, Arm pain got worse and worse. Patient is being treated at the hospital.
This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer sponsored program. A 47-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was allergic to other: pneumococcal vaccine on an unspecified date with outcome of unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Vaccine administered intramuscularly in left arm. Arm began to swell around injection site immediately after need was removed. Small area of ecchymosis developed just below injection site with swelling around the injection site, about 2 to 2.5 inches in diameter. Ice was immediately applied for 15 minutes. Patient was observed for 15 minutes. Swelling did improve after the 15 minutes of icing. No additional rash, swelling, itching developed. The patient had no trouble breathing, no itching or swelling of face, lips or throat, no dizziness. She was instructed to take Benadryl and ibuprofen when she got home, to go to the ER for worsening swelling, new rash, itching of body, dizziness, swelling or itching of mouth, lips, face or throat. She was instructed to follow-up with her PCP the next day if not continuing to improve. I did attempt to call patient today for an update, but was not able to speak with her as of now. I did leave a message asking her to call back with an update.
Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection".  Clinical information: The patient was fully vaccinated and boosted (1 booster) and had Breakthrough COVID infection. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right thigh swelling, redness, warm to touch.  Reminded mother to rub area every 2 hrs. and apply ice pack first 24 hours then warm compress.  Call PRN if increased redness & swelling.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-Nov-2009 the patient was vaccinated with the first dose of PNEUMOVAX23 0.5 ml, intramuscular (lot number, site of administration not reported). Subsequently, on 28-OCT-2014 the patient received the second dose of PNEUMOVAX23 0.5 ml, intramuscularly (lot number, site of administration not reported). No adverse effect was reported. Additional information has been requested.
Soreness, burning, inability to raise arm over head consistent for approx. three weeks. Phys prescribed Flexeril and cellebrix to have x-rays 12/13/05
This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Patient stated he is allergic to Amoxicillin where he didn't have a rash reaction until 8 to 10 days later. On 12Feb2021, patient experienced swelling in his left armpit, the same side where he received the shot, little swelling in the right armpit. On an unspecified date in Feb2021, patient experienced little swelling of the arm. The outcome of the event little swelling of the arm was unknown, swelling in his left armpit, the same side where he received the shot was recovering, little swelling in the right armpit was recovered on an unspecified date in Feb2021.   No follow up attempts are possible. Information about Lot and batch number could not be obtained.
I had fatigue; couldn't stay awake; fever (102.8); nausea; lose of appetite; cough - started when I got up on Friday, April 16th and lasted until Saturday afternoon, April 17th.  I felt like I had COVID all over again only worse.
Second dose of vaccine got missed; it passed 42 days and now it's 47 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine got missed; it passed 42 days and now it's 47 days after first dose) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine got missed; it passed 42 days and now it's 47 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine got missed; it passed 42 days and now it's 47 days after first dose) had resolved.        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.   Concomitant product use and treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non-significant follow up
Joints hurt from first vaccination, tired, arms low level of pain, running nose on day of injection
1. Given influenza vaccine in am, pt called back complaining of hives chest tightness, sent from work to ED.
After the vaccination, I had pain on top of my feet and ankles. I put ice on and was gone. I was tired for 24 hours. After a couple of days later, I woke up shaking and then I contacted my doctor. The doctor said to take another pill. It went away a week later. My blood pressure was high, and my heart rate was under 90. After a week, I went back to the doctor, and I just felt really weird. I had to go to the ER directly. They ran an EKG and blood work, and everything was normal.
Information was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, 4 doses of improperly stored PROQUAD (lot# M006102, expiration date 01-AUG-2017, recombinant human albumin (rHA), dose and route unknown) was administered to the unspecified patients. No adverse effect was reported. Additional information has been requested.
Patient reported pain, redness, swelling.  Was seen by PA who diagnosed an allergic reaction and prescribed Hydroxyzine 10 mg and Triamcinolone 0.025% ointment. Drew line around the area and told her to return if redness spread.
Information has been received from a RN concerning an 11 yr old white female who on 15Jun95 was vaccinated with a second dose of varicella virus vaccine live (lot number and route unk). There was no concomitant medication. On 25Jan06 the pt developed 2-5 lesions on her arms, trunk and forehead. Unspecified medical attention was sought and treatment was given for symptoms. Subsequently, the pt recovered. Follow up information received on 16Feb06 indicated that no additional information is available.