chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of injection site; soreness at injection site; tenderness in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 12:45 (Lot number: EN6199) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL AND CHLORTHALIDONE taken for hypertension, start date: 2010 (ongoing). The following information was reported: TENDERNESS (non-serious) with onset 09Mar2021, outcome "recovered" (10Mar2021), described as "tenderness in left arm"; VACCINATION SITE SWELLING (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Swelling of injection site"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "recovering", described as "soreness at injection site".  Additional information: Caller received the first dose Covid-19 vaccine. The day after, she had tenderness in her left arm. It went away and she was fine. This morning the injection site was very swollen and sore again. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The adverse events did not require emergency room visit. The patient did not receive any other vaccine within four weeks. The patient did not perform any relevant test.   No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA Five days after vaccine in L arm, L axillary lymph node edema appeared - tenderness to area when palpating but no pain
diarrhea, N/V; vomiting so severe that he was vomiting blood, tore esophagus, and was hospitalized." Narrative:
I've developed hives around my midsection. They are mostly 2mm in diameter and about as dense as 6 spots per square inch. They are itchy and swollen. I started noticing the effect about 4 days after the second vaccination, but I didn't make the connection to the vaccination as being a cause until 6 days after. I've started to apply over-the-counter anti-itch cream as needed.
Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # K000943, expiration date 24-SEP-2016, strength, dose, frequency and route were unknown). No adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested.
c/o of facial rash & itching 24-30 hrs p/vax;
Patient was given her second booster on 4/7/22.  She was given first booster on 2/15/22.  Minimum interval between the two doses is 4 months.
Patient fully vaccinated and boosted with Pfizer on 7/6/2021, 7/27/2021 and 1/5/22. Presented to ED on 1/8/2022 with upper respiratory infection. Patient prescribed Augmentin and told to follow-up with PCP upon discharge.
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group and Regulatory Authority. The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 03Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 60 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN, start date: Dec2018. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", described as "indication=Treatment of COVID-19"; COVID-19 (medically significant) with onset May2022, outcome "not recovered", described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative; (May2022) positive; (17May2022) positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: The patient Took Paxlovid within 12 hours of first symptom (within 8 hours of testing positive). Took full course of drug. Tested negative for COVID with antigen test on Day 6. Started feeling slight cold like symptoms on Day 8 with full blown symptoms on Day 9, body aches, chills, bad head cold. Tested positive on Day 12 with antigen test (first day tested since symptoms started). No follow-up attempts are needed. No further information is expected.
Felt immediate cold down left arm. Within minutes, arm felt like it was in an ice bath. Then lips started tingling (felt like swelling). (minute 5). Then dizziness (minute 7). Then tingling spread to face and forehead (15 minutes). Pharmacist stayed with me and we moved my chair outside. I drank water. Tingling feeling started spreading through arms and legs and came in waves. Lightheaded and nausea started around 30 minutes. Pharmacist stayed with me for 2 hours. Symptoms did not worsen but did not subside and tingly feeling kept coming in waves moving to different parts of body. Husband drove to pick me up from store and we took Benadryl. It is 8 pm now. Tingly feeling in face, arms, and legs is still there but much less pronounced.
Complete heart block; Light headed; has eczema on his elbow which is really red and itchy; Rash on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bundle branch block right.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) (seriousness criteria hospitalization prolonged and medically significant), DIZZINESS (Light headed), ECZEMA (has eczema on his elbow which is really red and itchy) and RASH (Rash on arm). The patient was hospitalized for 5 days due to ATRIOVENTRICULAR BLOCK COMPLETE. At the time of the report, ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block), DIZZINESS (Light headed) and ECZEMA (has eczema on his elbow which is really red and itchy) outcome was unknown and RASH (Rash on arm) was resolving.            Treatment medication included prescription cream for rash and cardiac pace maker implantation.   On 07 Apr 2021, post vaccination, the patient reported feeling really lightheaded and developed a horrible rash on his arm. The patient went to the hospital and was admitted for 4 nights and 5 days. During the hospitalization, it was confirmed the patient had a complete heart block and required a pacemaker to be implanted.  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 case was linked to US-MODERNATX, INC.-MOD-2021-090429 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-090429:Crosslinked case
Syncopal reaction within 1 minute of receiving 1st dose of Pfizer COVID vaccine. Episode was witnessed. No injury occurred. Pt had some orthostatic changes for approximately one hour after the event, but stabilized with rest, juice, crackers. He was examined by a physician and cleared for discharge from the clinic approximately 1 hr and 20 mins after vaccine administration.   Pt was already at the clinic, so clinic visit was extended beyond expected duration, but no other follow up was recommended at the time of discharge from clinic today.
This spontaneous prospective pregnancy report was received from the patient's mother refers to a female patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL, injection (dose, dose number, strength and lot number were not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient tested positive for pregnancy with unknown LMP (last menstrual period), EDD (estimated delivery date) and date of conception after received GARDASIL. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Patient reported extreme pain on shoulder, back, chest and elbow on left side, possible hives on arm that are itching, loss of appetite and weakness and dizziness. Recommended patient to use BENADRYL and acetaminophen to help with symptoms and contact her primary care doctor on further treatment recommendations.
no adverse event; Inbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.  ?    Names of vaccines invo; This spontaneous report was received from a medical assistant with a physician and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2023, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection which was improperly stored for 1 hour 30 minutes 0 seconds in temperature of - 12.48 degrees Celsius (C), no previous temperature excursion (Improper storage of product in use), (lot #x006983, has been verified to be a valid lot number, expiration date was reported as 07-MAR-2025), administered subcutaneously for prophylaxis (strength was not provided). No symptoms reported. No additional adverse event (AE)/PQC.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA009014:
he passed blood in urine; hematoma formation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as "Age:79, Unit: Unknown") received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 at single dose COVID-19 immunization; and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included blood in urine in 2020 (about a year ago). The patient's concomitant medications were not reported. The patient was on Eliquis. He received the COVID vaccine on 30Jan2021. On the 06Feb2021 and 09Feb2021, he passed blood in urine. He reported a similar experience about a year ago for the 1st time after which he saw a urologist who told him it was okay. He is also scheduled to see his urologist on the 25th for a 1-year follow-up. The patient would like to know what the connection is between the COVID vaccine and being on a blood thinner. On unspecified date in Feb2021, the patient had hematoma formation. The action taken in response to the events for suspect drug apixaban was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt exp fever of 103 f after tylenol, vax given 3 days before
Information has been received from a registered  nurse (R.N.), concerning a 12 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported.  It was reported that on an unknown date the 12 years old patient received a dose of ZOSATAVAX 0.65 ml per subcutaneous route (lot # and expiration date were not provided). Concomitant therapies were not provided. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
pyrexia; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and PYREXIA (pyrexia) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A2114) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Felt tired). On 14-Mar-2021, the patient experienced PYREXIA (pyrexia). On 14-Mar-2021, FATIGUE (Felt tired) had resolved. At the time of the report, PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Pyrexia: 101.3 (High) 101.3 and 103.3 (High) 103.3 for 2 hours before dropping.         concomitant medication information not provided.  Treatment provided is none.
General flu-like symptoms beginning roughly 12 hours after shot, and lasting roughly 24 hours: headache, exhaustion, overall muscle stiffness/soreness, some fever symptoms with cycles of low level chills and sweats. Slight soreness and redness around the site of injection.
Aching arm for 2+ days, headache, lethargy, stomach ache, loss of appetite, sleeplessness, anxiety. Last week +.
Within 5 hours, my arm swelled up. It turned bright red, with a rash, by evening, I had lesions with clear fluid on top of the rash. It has now been 48 hours, and I still have a swollen arm and red rash covering my bicep and triceps. I have had about 8-12 lesions that have popped.
Reporting vaccine administration error.  Patient  received Varciella (Varivax) vaccine when she was intended to get Shingrix Vaccine. Patient was seen on 2/28/22 and Shingrix Vaccine was ordered. Provider asked LPN to give Varicella Vaccine. Worker grabbed Varivax and when attempting to document it would not let her chart and they assumed that the order was wrong since NDC did not match and not that the vaccine was wrong.  Varivax was given to the patient.
injection arm is swollen and aches; seems like having Covid-19 again; bone, joint and body ache; red circle around the injection site; nausea; wants to throw up; injection arm aches; tired and sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced FATIGUE (tired and sleepy). On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medications were reported.
Deep muscle pain in deltoid for 3.5 weeks. Treatment with Motrin, ice, physical therapy ordered.
No patients experienced symptoms.; Impropertly stored doses of varivax were administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S036637 has been verified to be valid; expiration date reported and validated as 14-NOV-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of 17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptom.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2006USA001815: US-009507513-2006USA001819: US-009507513-2006USA001641: US-009507513-2006USA001816: US-009507513-2006USA001817:
This 70 year old white  male received the Covid shot on  1/29/21    and went to the ED on  3/27/21     and was admitted  on 3/27/21 with the following diagnoses listed below. I26.99 - Bilateral pulmonary embolism  I26.99 - Pulmonary embolism, bilateral
Dose received was a booster dose for this patient.  Vaccines had an expiration date of 03/27/2022. This specific lot number had been taken out of the freezer beginning of March. No cases of adverse reactions have been reported.
29oct96 6 am awakened feeling feverish; noticed red spots on abd spreading to whole body & limbs. reported to hlth dept & saw MD who Rx anti-itch topical meds. 26nov96 recovered completely in about 4 days. continues on same meds w/ no
Fever, chills, body aches. Started 24 hours after first dose. It lasted for about 20 hours.
NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 02-OCT-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose 0.5 ml (milliliter), route subcutaneous (dose, route reported as in prescribing information), strength, product lot #, expiry date not reported) that was  improperly stored. There was no information on concomitant therapy. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Pt received a flu vaccine, with no incident. About 5 minute received report pt had fainted. Spoke to pt, who was on floor at time and he stated he gets lightheaded when giving blood or vaccinated.
Patient received last years flu shot strain (2016-2017 formula) exp. 08MAY17.
Anti-GBM; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (PRIVACY)    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) (seriousness criterion medically significant). The patient was treated with CYCLOPHOSPHAMIDE for Anti-GBM disease, at an unspecified dose and frequency. At the time of the report, ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) to be possibly related.    No concomitant information were reported. Patient was also treated with Steroids and plasma exchange.  This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of  ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM).The event occurred after  a dose of mRNA-1273 Moderna vaccine ( doen´t clarify if it was 1st or 2nd dose). The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-371317 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email received from team and contains new information. Event outcome and treatment medications were added.; Sender's Comments: This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of anti-glomerular basement membrane disease (Anti-GBM). The event occurred after a dose of Moderna COVID-19 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
COVID moderna booster was given at incorrect dose, was give 0.5ml when should have been given 0.25ml
have experienced pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in unspecfied number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that a lot of patients had experienced pain after receiving the Shingrix vaccine.  The reporter did not consented to follow up, No further information was available. This case was linked with case US2020228543 reported by same reporter. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228543:Same Reporter
On 5-8-08 she received HIB, Prevnar, MMR and Varicella vaccine at noon.  On 5-10-08 at 6 PM she developed a fever of 100.0 rectally.  "A few hours later" per mom it was 104.0 rectally.  She was taken to ER where labs were drawn.  No difinite diagnosis was made - "could be from the shots".  Temp remained 100 rectal during the day and highter at night - 103.7 on 5-12-08.  Temp broke on 05-14-08.  Back to normal on 05-16-08.