chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 73 year old female patient. The patient's current conditions included unspecified heart condition and penicillin allergy. Historical medication included penicillin. Concomitant medication included amlodipine and aspirin (manufacturer unknown). On 19-MAR-2018, the patient was administered PNEUMOVAX 23 (lot and expiry date not reported) to prevent pneumonia. The patient experienced a fever and fatigue after receiving a PNEUMOVAX 23 on 19-MAR-2018. The patient also experienced pain and soreness on the opposite arm of the injection. The patient described the feeling as "hot to touch". The patient saw physician and took unspecified treatment for the events. Outcome of the events was not recovered. Causality assessment was not reported for the events.
Large swollen red hive-like spot at the injection site! Itching and it was hot! Made my whole arm hurt even into my shoulder and clavicle. Still red and swollen 4 days later!
booster; tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Clinical course: She had mild symptoms. Runny nose, congestion, headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Will get revaccinated
On 6/13/2021, patient had chest pain and presented to emergency room and noted to have elevated troponin concerning for myocarditis. He was hemodynamically stable and echocardiogram showed normal function. He was admitted to  pediatric ICU and monitored and troponin trended down on 6/14/2021. Patient was clinically stable during admission. Cardiac MRI is pending at the time of report filing and patient is currently inpatient with anticipated discharge in the next 1-2 days.
pt recv 4/23/98 varivax & mmrII. following day pt devel blisters & red patches.
Red and raised hives all over stomach, chest, groin, back, armpits,  neck. Continued to spread over 18-24 hours.  Hives did not itch. Took Benadryl which faded them but didn?t make them go away completely. They were gone within 2-3 days.
Shoulder pain after first dose; This is a spontaneous report from a non-contactable consumer. This consumer reported events for two patients. This is first of two reports. A patient of unspecified age and gender received 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 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder pain after first dose on an unspecified date. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452678 same reporter and drug, different patient and event
Cardiac arrest; pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and PULMONARY EMBOLISM (pulmonary embolism) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Resuscitation.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening) and PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and life threatening). At the time of the report, CARDIAC ARREST (Cardiac arrest) and PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to a 1 year old patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 15-FEB-2018, the patient was vaccinated with two doses of VARIVAX (dosing details, lot # and expiry date unknown) for prophylaxis. No known adverse effects reported. No product quality complaint (PQC) was involved.
Information regarding PREVNAR was received from a patient's mother regarding her 4-month-old son who experienced injection site swelling, body tremors and injection site inflammation. The patient received a dose in Apr-2008. In 2008 the patient was administered PREVNAR and the following day experienced injection site swelling and injection site inflammation. Three days later, he experienced "body tremors" which lasted a few seconds. The mother stated that these were not seizures and there was no fever associated with the reaction. She also stated that the child recovered fully but not has been rechallenged with PREVNAR. No additional information was available at the time of this report.
Patient received vaccines on 10/29/09 at 4:40 PM.  According to admission note, patient went to ER on 10/31/09 at 10:28 AM.  Stated he had pain and at injection site since administration.  Applied ice the day prior to ER visit to help decrease swelling.  Arrived to ER with 7 x 7 cm induration and swelling on left arm at side of Menactra injection.
Approx 3 weeks after receiving flu vaccine, pt began to experience numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms in legs. MD suspects Guiallan-Barre Syndrome. Still experiencing symptoms. The medical records received on 1/9/04 states weakness and fatigue.   Nurse follow up on 06/28/04 states: "ADD: Osteopenia."
This is a spontaneous report from a contactable consumer that reported for her daughter and from a contactable nurse. An 18-year-old female patient received TRUMENBA, (Lot. M77282, Expiration date: Jun2017), intramuscular, at 0.5 ml, single dose, intramuscular in the left upper arm, on 06Sep2016 at 15:00, for immunization. The vaccinated at private doctor's office/hospital, and it was purchased with private funds. The patient medical history was not reported. Concomitant medication included naproxen 500 mg as needed, from 21Aug2013 and ongoing, for dysmenorrhea. On 06Sep2016, the patient experienced pain at site of injection with outcome of not recovered, her body aches all over/body ache on an unspecified date with outcome of not recovered, sleeping a lot on an unspecified date with outcome of unknown, napping out a couple of hours on and off on an unspecified date with outcome of unknown, tired/fatigue on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of pain at the injection site and body aches included Tylenol. The nurse considered that there was a reasonable possibility that events was related with the suspect product meningococcal group b rlp2086. Follow-up (04Oct2016): New information received from a contactable nurse includes: suspect drug and concomitant medications details. Follow-up attempts completed. No further information expected.
mild headache; Soreness of right arm,; This is a spontaneous report from a contactable pharmacist.   A 36-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 24Feb2021 14:30 (at the age of 36 years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021 12:00, the patient experienced mild headache, soreness of right arm. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any treatment for the events. The outcome of soreness of right arm, mild headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Fever, Pain/Discomfort at injection site, fatigue Narrative:
pt recv vax 1MAR96 & 4MAR96 pt devel a positive TB skin test (12mm x 11mm) when given vax;it was noted that the pt parents stated that their daughter had no contact w/TB positive person since last neg TB skin test in MAR95
1/9/21 -1/11/21- extreme pain to left arm and shoulder, unable to lift arm or rotate back to wipe behind. Took ibuprofen, iced left arm, rested. 1/11/21- had telephone appt with pcp provider- X-ray of left shoulder ordered, orthopedic referral, and tylenol #3 for pain 1/12/21- went to urgent care due to extreme pain to left shoulder-received prescription for ibuprofen, voltaren gel, rest, continue ice packs, take Tylenol in between ibuprofen if continue to have pain.  1/13/21-finally had some pain relief-able to move arm better, still could not life arm straight, continue to have trouble rotating left arm to wipe behind, noted intermittent numbness to left arm. 1/14/21- able to move left arm okay but still not 100%, still cannot raise left arm fully, able to rotate back but can still feel soreness.  1/15/21-1/21/21- able to move left arm and rotate shoulder backwards to wear a sweater but can still feel left shoulder soreness, can left left arm straight up but can still feel muscle soreness to left shoulder.
Rec'd shots on Friday & on saturday night, mom noted red welt on leg and red area going down leg. Sunday am baby woke up screaming. Leg sore to touch, Mom took him to ER. Gave him script for antibiotics.
No adverse event; The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023; Accidentally administered 2 doses of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023), EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023) and EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023), EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023) and EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster).    No concomitant drug information was provided.  It was reported that by the pharmacist that they accidentally administered 2 doses of the bivalent booster doses (6 months - 5 years old) to 2 patients. Vaccine was initially stored in refrigerator on 22Dec2022.  No treatment drug information was provided.  The case was reported for one of the two child patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706642 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706642:Master case
I am not able to move my left arm without feeling strong pain.  I felt nauseated, dizzy, and a headache. As if I was drunk.
Patient reported feeling dizzy about 2-3 hours after vaccination. He sat down in a chair and claims that he became comatose and could not move for 2 hours.
Distorted vision in right eye; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 29Apr2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 11:00, the patient experienced distorted vision in right eye. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event distorted vision in right eye was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of inappropriate age of administration in a 42-month-old unk patient who received KINRIX. On an unknown date, the patient received the 1st dose of KINRIX. On an unknown date, on unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received on 13 November 2014: The 3.5 years old patient was inadvertently given a dose of KINRIX. The reporter was unaware of whether it was given as primary series dose of as the 4th DTaP. No adverse event was reported.
Patient received vaccine in right deltoid.  The next day he called to report redness and swelling down to the elbow.  Advised patient to use ibuprofen and cold compress for pain and diphenhydramine and to observe administration site.  Patient called back later to report no change after several hours.  Advised patient to seek medical treatment if condition worsened.
Information has been received from a registered nurse referring to a 12 month old female patient. This patient has no relevant medical history, concomitant medications, or drug history. On 25-MAY-2016, the patient was accidentally given GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, 0.5 ml, intramuscular) instead of the LIQUID PEDVAXHIB. This was also off label administration because of the patient's age. No adverse events had been reported to the facility thus far. This patient had not relevant laboratory data. As of 25-MAY-2016, the reporter stated that they would not be administering GARDASIL 9 to the patient again, and the outcome of the of off label administration as well as accidental administration was unknown, however nothing had been reported yet. Additional information has been requested.
PT DEVELOPED LEFT FROZEN SHOULDER THE DAY AFTER HE RECEIVED SHINGRINX VACCINATION #1 IN LEFT DELTOID.  HE REPORTS THAT HE IS "SURE THAT VACCINE WAS RECEIVED IN THE DELTOID."  HE REPORTS PREVIOUS HISTORY OF LEFT FROZEN SHOULDER IN 2013 OR 2014 FOLLOWING A FLU SHOT THAT WAS "MOST LIKELY INJECTED INTO AN INTERSTITIAL SPACE NEAR THE LEFT SHOULDER JOINT."
Developed high blood pressure, and respiratory problems that require medication. Was always healthy until I got the shot.
Enlarge lymph nodes under left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlarge lymph nodes under left armpit). At the time of the report, LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) outcome was unknown. Not Provided
palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of injection site; muscle soreness on arm of injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization in a hospital. Medical history included GERD and Strep throat, both from unknown dates.  Concomitant medication included benzylpenicillin (PENICILLIN). The patient did not receive other vaccine in four weeks. The patient experienced palpitations - 3 days straight skin rash with itching on her left leg, muscle soreness on arm of injection site, all on 31Dec2020 11:00.  The events were reported as non-serious. The patient did not receive treatment for the events. The patient had not recovered from the events.   Information on the lot number/Batch number was requested.
Developed hives and itching on bilateral shoulders, arms, legs, trunk at 1300 on 12/17/19, 3 hours post injection of HPV Gardasil 9 #2 injection. Denied any SOA or hives on face or neck. Seen at 10:00 AM on 12/18/19 by NP for remaining hives on lower right leg. No other symptoms present. No treatment given.
Iritis; This case was reported by a other health professional via sales rep and described the occurrence of iritis in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced iritis. On an unknown date, the outcome of the iritis was unknown.   The reporter considered the iritis to be possibly related to Shingrix.  Additional details were provided as follows: The patient received  a dose of shingrix at a pharmacy and followed up with 2-3 weeks later with Iritis that had been happening since shortly after he received the dose of Shingrix.  The reporter was concerned that it could be vaccine related.
He could die from it; jaw swelled up again; received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment; swollen jaw; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (He could die from it) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (he gets the Flu vaccine every year.). Concurrent medical conditions included Blood pressure high, Diabetic and High cholesterol. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SWELLING FACE (swollen jaw). On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (He could die from it) (seriousness criterion medically significant) and SWELLING FACE (jaw swelled up again). At the time of the report, NEAR DEATH EXPERIENCE (He could die from it) and SWELLING FACE (jaw swelled up again) outcome was unknown and SWELLING FACE (swollen jaw) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) COVID-19 antibody test  negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
A report was received from a health care professional on 11/18/02, concerning a 46 year old female vaccinee, who was also a health care professional, who experienced muscle degradation and pain at the injection site 7 days after receiving Fluvirin on 10/30/02. On 11/06/02, the vaccinee experienced muscle degradation and pain at the injection in the left deltoid muscle. The degradation was reported to be worsening, involving an area of 5cm. In 1998 the vaccinee was reported to have had a similar experience after receiving influenza virus vaccine (brand unspecified). However, the vaccinee was reported to have tolerated influenza vaccinee (brands unspecified) in the past. The reporter has assessed the relationship of the event to the vaccine as possible.
4/29/11 pain, redness, burning & itching, little raised bumps. 4/30/11 same as above. 5-1-11 pain not as bad. 5-2-11 - 5-3-11 slight pain, some redness & itching.