chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cll/sll" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Penicillin sulfates. Concomitant medication(s) included: CALQUENCE, start date: 31Dec2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: The patient took other medication in 2 weeks. The patient received COVID 19 Treatment with start date reported as 16Jun2022 and stop date as 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 11:00 as a single dose (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. The patient had known allergies to morphine. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 12:15, the patient experienced injection site soreness. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event injection site soreness was recovering, at the time of this report.   No follow up attempts are needed; Information on lot/ batch number cannot be obtained.
This is a spontaneous report from a contactable consumer. This male patient of an unspecified age and ethnicity received the second single dose of TRUMENBA via an unspecified route of administration on 14MAY2015. The patient medical history and concomitant medications were not reported. On 14MAY2015 the patient felt achy, really shaky and as he was going to faint and to pass out, dizzy, lightheaded and weak. His head hurt a little bit. The patient was not recovered at the time of this report. Follow-up attempts completed. No further information expected.
On 11/07/2022, I started experiencing symptoms of fever, body/joint aches and persistent/non-productive cough. I went to the doctor because of my symptoms, and they tested me for Flu, COVID and RSV. I tested negative for Flu, but positive for COVID. I was given a shot of prednisone, a prescription to take for 5 additional days and a prescription for cough syrup. I did not feel that this medication helped and I was prescribed an additional round of steroids. As of today, 12/20/2022, I am still not feeling better. Prior to getting COVID-19, I was in good health, but now I am still feeling sick, have a cough and feeling fatigued.
Information has been received from a physician concerning a 15 year old female patient who on 09-DEC-2010 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 666949/0888Z), 0.5ml. Immediately after receiving the vaccine the patient turned pale and became dizzy. The physician had her relax in the office and gave her cookies and juice. No lab diagnostics studies were performed. The patient recovered before leaving the office. The patient has not followed up with the office with any other reactions. Follow up information has been received from the physician concerning the patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 09-DEC-2010 at almost 3:00 PM was vaccinated with the second dose of GARDASIL into the right arm. Shortly the physician found that the patient almost fainted and turned pale. Blood pressure was measured with the result of 74/64. She was remained after lying on the table and recovered few minutes after the vaccination. Repeat blood pressure was measured with the result of 95/67. Heart rate was 100. The patient did not have any adverse event following prior vaccination. Additional information is not expected.
arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EW0150) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mmr (NDC, LOT number and expiry date: Unknown), administration date: Dec2020, reaction(s): "localized reaction". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional Information: Additional Administered Vaccines  was reported as none. Prior Vaccinations (within 4 weeks) were none. Family Medical History Relevant to AE(s) was none. Reporter stated she was calling about the BioNTech COVID 19 vaccine. she stated she received the first dose today and she does not see anywhere in the paperwork for what she can take for side effects? she wanted to know if she could take Tylenol or Benadry? she stated she would call her doctor and follow up. reporter stated the side effects she is having is arm pain and headache. Event did not required a visit to Emergency Room or Physician Office.    No follow-up attempts are needed. No further information is expected.
11 days between both doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
This spontaneous report was received from a female patient of unknown age. On an unknown date in 2007 the patient was vaccinated with doses 1 and 2 GARDASIL (lot #, expiration date and route not reported). She never received the third dosage. She did not report any side effects. Additional information is not expected.
Information has been received from a health care professional concerning a 74 year old female with a hiatal hernia and degenerative joint disease who on 9/2/99 was vaccinated with the first dose of Hep b, IM. On 9/3/99 the pt experienced an itchy rash all over, with redness at the injection site. She sought unspecified medical attention and was treated with three doses of Banadryl, which didn't help the itch. No further information is available.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot# K002831, expiration date 15-JAN-2016, dose, dose# and route unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
41 y/o  M AD presents 11 days s/p SPX vaccine. Patient endorses L shoulder stiffness and pain, erythema, edema, and large spot where vaccine was given. On exam patient has large 2-3cm pale, ulcerated lesion w/ central necrosis. Underlying this is a indurated nodule of slightly larger circumference. Surrounding area of approximately 8cmx8cm is erythematous and warm w/ minimal induration. Larger area appears to be caused by allergic reaction to adhesive bandage.
gen hives appearing about 18hr p/vax;no other signs of illness or rxn;
1. Fatigue - starting 4/1/2021 at 5pm, becoming significant 4/2/2021 morning and lasting all day, becoming mild and lasting for a couple weeks 2.  Headache - moderate to severe starting 4/2/2021 morning lasting all day, mild headache for another couple days 3. Nausea - moderate starting 4/2/2021 morning lasting all day  4. Fever - low grade (100.1) 4/2/2021 starting morning resolving by 5pm 5. Injection site discomfort - mild starting 4/1/2021 and lasting a couple days
Patient had itchy throat. Gave Benadryl 25 mg IM, itchy throat resolved and throat felt more "relaxed". Patient stable, released from vaccination site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 29Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Subglottic stenosis" (unspecified if ongoing); "Know allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Know allergies: Azythromacin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Other medication in 2weeks was Yes. The patient was taking any other medications products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. vaccine received was Yes.  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
Rash, fever, chills, joint pain, body aches, nausea, sore throat, diarrhea, fatigue, headache, swelling in throat, dizziness
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 24-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
flu like symptoms; light headed; achy; nausea; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, light headedness, pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, light headedness, pain and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, light headedness, pain and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. At about 5 PM, the patient received Shingrix. Next day of vaccination, the patient had flu like symptoms, nausea, light headed and very achy they lasted for several days with improving gradually. This case was linked with US2019AMR083761, reported by the same reporter.
swollen lymph nodes Narrative:  employee states: her lymph nodes became swollen a few days after the injection
As the vaccine was injected, I felt a strong pinch (this was after the needle was inserted) and then a tingling in the hand and fingers in the injected arm, like "pins & needles" when a limb "falls asleep."  It stopped about three minutes later, but has returned DAILY and occurs sometimes 20 to 30 times a day.  Some tingling periods last 30 to 60 seconds, and others go on for 3 to 5 minutes.  I have full use of the hand at that time, but it is very distracting and wakes me up at night.  My doctor thinks that a nerve was affected by the vaccine and does not know how long the damaged nerve will be like that.
PERIORBITAL SWELLING (FAMILY HISTORY OF PERIORBITAL SWELLING WITH CERTAIN CERTAIN MEDICATIONS & PRESERVATIVES).
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 44 year old female states that she is sore and tender at site of injection. There is approx. 1 1/2" to 2 1/2" in diameter that is slightly raised and hard/knot and hot to the touch. She denies nausea and vomiting but does have a mild headache. She has received influenza vaccination before without incident. she is suffering from a "slight" sinus infection and denies any history of alleries. Follow up #1 06/19/02: During internal auditng of all flies, it was deemed necessary to amend the report by updating the Adverse Event coding  (Added Medication Error and re-ranked Adverse Events).
p/vax pt exp varicella w/over 45 lesions but only a mild temp;
Day after:  chills, fatigue, bodyaches 3 weeks after:  bells palsy
Myalgia, Arthralgia, swelling, itching at vaccination site  Narrative:   Other Relevant History:
fever, chills, severe aching-pain, mild nausea;t101.8 resolving @ 244hr;
24 Hours after the injection, 3 lymph nodes on the left side neck appeared 2 lumps on left breast Went to doctors office 9/21/22 Woke up with stiff neck 3 weeks later Touched left side, felt bumps on the neck Went to doctors office 10/18 and had US (Ultrasound) and labs done  US showed lymph nodes  11/10 during biopsy the lymph nodes are bigger  today 11/28, the lymph nodes feel bigger, having headaches, pain in neck, left side ear lobe pain, unable to rotate neck
Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported progressive joint pain and weakness 2 weeks after receiving the vaccine. She stated that she had full range of motion and is able to raise the arm but experiences weakness for the arm. Advised to have it checked out by a physician as soon as possible to rule out any chances for injury following the vaccine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. No treatment information was given.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that an expired dose of the Moderna COVID-19 monovalent vaccine was administered to one patient (Exp date 06 Feb 2023)).    The vial size was 5.5 ml. The vial was initially stored in the refrigerator was 3APR2023  The vial did not undergo any temperature excursions. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2023: Live Follow-up received include reference section updated.
4hr p/vax pt had 15min of high pitched crying-leg swollen-taken to MD;MD reported no temp elevation in office but advises no more pertussis;
An 86 year old female patient developed a left side facial rash involving lips and cheek within two weeks of her second Moderna Covid-19 vaccination (first dose of vaccine received in Feb 2021, second in Mar 2021). The patient does not have a history of COVID infection, no history of dermatological conditions, no history of herpes, no history of autoimmune disease, no family history of autoimmune conditions. After several months of sustained rash (beginning March 2021 and continuing as of today 23 Sep 2021), throat clearing issues, numerous visits to dermatology, ENT, general practitioner, pulmonology, endocrinology the patient tested positive for ANA. Subsequent punch skin biopsy and additional tests resulted in a diagnosis of lupus on 07 Sep 2021. The patient is scheduled to meet with rheumatology in Oct 2021. Possibly a urologist as well. The onset of symptoms is notable post-vaccination and may be related to the Moderna COVID-19 vaccination.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.