chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right lower extremity leg pain started several days prior to seeing the doctor. On April 3rd was diagnosed with a RLE Deep Vein Thrombosis. Received lovenox treatment and Warfarn, then switched to Xeralto long term.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long COVID", start date: Jan2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 25Jun2022 to 29Jul2022.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Inflammation at the injection site.  Redness, swelling, soreness, hot to the touch on day 1. 2in diameter circle around injection site. Pink, less swollen, larger surface area, warm to the touch on day 2. Down the entire bicep in splotches.
No adverse event; 3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1, 0.5 ml) on 10-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, 0.5 ml) on 10-Mar-2021, Moderna COVID-19 Vaccine (Dose 3 and 0.25 ml) on 04-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 03-Mar-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713877, US-MODERNATX, INC.-MOD-2023-713958 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713877:Patient 3 case US-MODERNATX, INC.-MOD-2023-713958:Patient 2 case
Patient with large lump approximate size 5cm across and 3 cm wide red hot and swollen painful to touch. Pain extending into the left neck.
Nine weeks of pain, sent to Orthopedic Doctor followed by cortisone shot and steroids medicine. Physical therapy next as pain and limitations continue.
Chronic tension-type headache began 24-48 hours after vaccine administration and continued for at least 8 weeks (still occurring as of the time of this report). Headaches accompanied by significant cognitive difficulties such as loss of focus and concentration ability, short-term memory lapses, increased eye fatigue, and irritability. I am completely unable to perform my job, which requires computer work all day. Headache is constant nearly 24/7, severity varies. Headache worsens significantly after extended periods of focused work or concentration. I experienced similar long-term symptoms after the 2nd Pfizer dose received in June 2021, which came on gradually and lasted for several months. But after this dose, the symptoms came on much more immediately and severely.
Had severe body aches, extreme tiredness, fever 103.5 at the highest point. The body aches and tiredness symptoms lasted about 3 days.  The fever hovered around 101 for 3 days. Also had a cough that lasted a couple of weeks. Took advil to reduce fever.
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
pt recv vax; site of Hep B inject red on lt arm, swollen, mildly tender to touch; pt advised to apply ice & use apap;
Shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A patient of a pharmacist in a certain pharmacy chain needed the second dose next week but was diagnosed with shingles yesterday (10Mar2021). They wanted to make sure if it was still okay for the patient to receive the second dose. The outcome of the event was unknown.  Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.
Site of injection is hot to touch and sore about a day after injection given. Patient was told to take ibuprofen for relief.
dizziness, light headedness, clammy skin, inc pulse rate, inc BP; had pt lie down elevate legs, gave H20, monitored vitals until returned to nl ranges;
12-year-old patient received Moderna COVID-19 vaccine (only approved for patients 18 years and older). No adverse events reported.
Sore throat, nasal congestion; chest tightness; inflamed bronchial tube; dry cough; headache; fatigue. My symptoms started on sunday and I don't have a sore throat but have nasal congestion. Tightness in chest, headache and coughing is better. I've been taking extra strength Tylenol.
After receiving the shot, entire body was extremely sore, large red swelling around shot area, general feeling of illness for about one week.
Pt had significant worsening of migraines that became debilitating, with generalized weakness and decreased balance and instability. Pt has had multiple falls since the vaccination and report from ENT indicates vestibular migraines likely triggered by the vaccine.
I received the vaccine and within the next few days became pregnant about 1 month later - I found out I was pregnant on 5/10. I was hospitalized with an ectopic pregnancy and had emergency surgery to remove the pregnancy and the entire Fallopian tube on 5/12. I would have only been 5.5 weeks pregnant but was showing all other signs of a healthy early pregnancy when I went in for the test on 5.10. When I see the date of conception and date of covid vaccine - they are within a day of one another.  I would have died had I not gone into the hospital the day of the pain - the Fallopian tube was rupturing.
Patient entered the pharmacy on 10/15/23 asking if sore arm is a normal adverse effect 5- days after receiving the vaccine. I informed him that trauma to the muscle from the needle  does result in injection site soreness, but he stressed that he felt very uncomfortable. His arm had no signs of injury and there was no swelling or redness anywhere on his left arm.  Advised him to try ibuprofen OTC for residual pain.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022;  lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 10-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
given only the adjuvant; given only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 99-year-old female patient who received Herpes zoster (Shingrix) (batch number 9e995, expiry date 16th September 2022) for prophylaxis.   On 25th October 2021, the patient received Shingrix (intramuscular). On 25th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient have been given only the adjuvant instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
administered an expired act-hib with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) Vaccine HIB (PRP/T) VACCINE [ACT-HIB] strength, expiry date, lot number not reported via intramuscular route in unknown administration site for immunization and on the same day administered an expired act-hib with no reported adverse event (expired product administered).Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib with no reported adverse event.  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 the 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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 at 16:00 as dose 1, single (Lot number: EK9231), in right arm, on 22Jan2021 at 16:00 as dose 2, single (Lot number: 162b2), in left arm, on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 15Jul2022 at 17:30 as dose 4 (booster), single (Lot number: FM0173) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Chronic Bronchitis" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing); "Known allergies:  latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) positive; (08Aug2022) Negative; (13Aug2022) positive, notes: Rebound on 13Aug with worsening symptoms. Therapeutic measures were taken as a result of covid-19. Clinical course: COVID positive 03Aug2022. Started Plaxlovid on 04Aug finished 09Aug. Mild to Moderate case. Negative test on Monday 08Aug. Rebound on 13Aug with worsening symptoms, and positive test.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Dry cough, congested head, lasted ~2 weeks. Diagnosed as viral sinusitis after 1 week.
diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date and received the second dose on 15Mar2021 (at the age of 47-year-old), both via an unspecified route of administration at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, the patient was diagnosed with COVID-19 and currently still battling it. The consumer further reported that her husband had his second dose last week, on Monday (15Mar2021), and hers was given on Wednesday. She reported that they both tested positive for COVID on 20Mar2021, after, and they are still trying to beat it. The consumer wanted to know if having COVID-19 at the time of vaccination lessen the efficacy of the vaccine. The patient had not yet recovered from the events.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335455 same reporter/drug/event, different patient
Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Fainted 3P=120/64 at 10:15, pale in color, warm clammy skin.  Pt had not eaten breakfast.  Came too and was alert and oriented x3 rested on floor, drank juice, and was feeling better.  Color pink, pt. walked to car with parish nurse's husband at her side at 10:35
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026653, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
no additional adverse effect reported; temperature excursion/ was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741377 experienced the temperature excursion of 36 degrees fahrenheit (F) (30.48 F) for 0 hours 45 minutes and 0 seconds. On 22-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741377, expiration date 07-MAR-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No adverse event was reported (no adverse event).
Pain stiffness in left shoulder - went away after a four days Severe headache - took Tylenol and Ibuprofen - better after a couple days Severe body aches - took Tylenol and Ibuprofen - better after a couple days Severe fatigue - rested for two days Missed work for two days
Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 21-AUG-2023 The pharmacist reported that a female patient received first dose of Shingrix in 2018 but never received the second dose. The first dose was administered at a different location, so exact date and lot number and expiration date information was not available to the pharmacist. No additional dosing had yet been administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Day of - toes and fingers started tingling, extreme fatigue, light-headed Next day - extreme cold symptoms - fever, light-headed, stomach ache, stuffy nose, body aches, right deltoid (where shot was administered) hurt badly to move at all Day three - today - arm is still sore but no other side effects at this time
-Pain at injection site and sore arm, started an hour after vaccination,lasting for 24 hours now -Redness,swelling,warmth and pain on right foot, time course ongoing for more than 1 hour
Improperly stored dose; No adverse effect; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. On an unknown date, the patient received improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S025609, expiration date 18-AUG-2021 (strength, dose number, anatomical location, route of administration were unknown) for prophylaxis. Concomitant medications included sterile diluent (lot number and expiry date was unknown). The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit or minus 5.48 degrees Celsius for a time frame of 7 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
HCP calling to report temperature excursion for VARIVAX after being administered to a patient. Temperature 28.9F, Time frame 13 hours 59 minutes 54 seconds; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 29-JUN-2023, the patient was vaccinated with an improper storage varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot #X001000, expiration date reported as 09-JAN-2024, but upon internal validation established as 09-JAN-2025, for prophylaxis (route of administration and anatomical location were not provided). The vaccine had a temperature excursion at a temperature of 28.9 Fahrenheit (F) for a time frame of 13 hours, 59 minutes and 54 seconds. Temperature excursion assessment was supported.
Chills; This case was reported by a consumer via patient support programs and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for infusion for systemic lupus erythematosus.   On 26th December 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Benlysta at an unknown dose and frequency. On 27th December 2022, 1 days after receiving Shingrix and unknown after starting Benlysta, the patient experienced chills. The action taken with Benlysta was unknown. On an unknown date, the outcome of the chills was not recovered/not resolved.   It was unknown if the reporter considered the chills to be related to Shingrix and Benlysta.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: This case was reported by a patient via patient support programs. The patient stated that she received her shingles vaccine the day before reporting and was experiencing chills at the time of reporting. The reporter consent to contact was given.
The patient said that she now has shingles after receiving the flu vaccine and is concerned that the flu vaccine may have been contaminated with the shingles virus.
I very much doubt my health event had anything to do with the vaccine since it started so long after receiving the vaccine especially since it was the fourth one I had, but I noted it on my checkup anyway just to be accurate about my current health.   Health event was that my skin became extremely itchy all over my body with no visible rash for about three months. Was prescribed hydroxyzine, given a steroid shot, and have changed out all soaps for non-allergenic ones and condition has improved. Much more likely this health event was a newfound allergy, not a reaction to a vaccine I received half a year ago.