chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an other health professional refers to an unspecified number of patients, age and gender were not reported. On an unknown date the patients were vaccinated with GARDASIL via the intramuscular route in the gluteal region. Dose, strength, dose number, lot number and expiration date were not reported. On an unknown date GARDASIL was possibly administered as a subcutaneous injection. Dose, strength, dose number, lot number and expiration date were not reported. No adverse effect was reported. Additional information has been requested.
This is 3rd party information that was reports via the chart. I have not witnessed nor have I heard the report first hand.  Patient reports hives in her mouth at noon on 1/21/2023.   She took 1 Benadryl which improved the symptoms within she noticed a rash on her neck and she was feeling discombobulated.  She has history of allergies in the past.  No history of anaphylaxis.  No shortness of breath. Treatment: Given hives on neck and face recommended Benadryl 50 mg along with Solu-Medrol.  Patient refuses as she says that is too much Benadryl and she does not do well with steroids.  She would prefer 25 mg of Benadryl and to be observed.  Patient was observed for 1 hour and symptoms improved.  No sign of anaphylaxis. She was discharge with EpiPen although she has never had anaphylaxis.  Recommended that she continue Benadryl every 4-6 hours.
8/4/15 at 1300-gave HPV vaccine (only-no other vaccines) with 20-30 sec syncopal episode approx 2 min after administration.
Patient came in approximately 2 weeks after shot was administered stating that her arm was still sore. We advised that this may happen and should have it examined by a physician. Patient then went to provider and had medication prescribed to help with the discomfort. Patient then came in again 10/30 advising that medication did not help.
Pfizer COVID vaccine #3 given 12/17/2021, lot # FE3594;  pt had a positive COVID test on 2/11/2022, ordering facility  Hospital; 3/30/22 admitted to hosp with acute renal failure, acute hypercalcemia, acute encephalopathy, dx with multiple myeloma; took 3 rounds of chemotherapy; no renal failure improvement; suffered 2 PEA arrests and did not survive the second one.
Fainting for about 30 seconds to a minute in the bathroom; Feeling dizzy; Could not stand for a while when fell; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell). On 07-Apr-2021 at 4:00 AM, the patient experienced SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) (seriousness criterion medically significant). On 07-Apr-2021, DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell) had resolved. On 07-Apr-2021 at 4:01 AM, SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) had resolved.            No concomitant medications were reported. Treatment included for the events was acetaminophen. Patient reported that he felt dizzy and fainted for about 30 seconds to 1 minute in his bathroom at around 4:00 am this morning after receiving his second dose of the vaccine yesterday on 6 April 2021.Also, he could not stand for a while when fell. The patient took energy drink. Patient confirmed that the symptom was one time and it has not come back.; 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.
High fever, nausea, lethargic, loss of consciousness, headache, dizziness, tight throat, trouble breathing, rash/hives, anaphylaxis.
Breakthrough Case admission after 2 vaccines Pfizer 1/27/21 Lot3 El9261;  Pfizer 2/17/21 Lot# EL9265
Recipient came to mass clinic for what was thought to be his FIRST COVID vaccine, however he had received a COVID vaccine from Employee Health on 2/8/2021- Moderna Lot #012M20A also in left deltoid, IM route. No adverse events were reported from the patient to local Health Department regarding this vaccine. Verification was done by local staff confirming that both vaccines were given and there are no other duplicate clients with same name/similar demographics.
I'm so sick; feel like I have the flu; can't move my arm hurts so much; can't move my arm hurts so much; my temp is 101; i have headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering. On an unknown date, the outcome of the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the sickness, influenza-like symptoms, pain in arm, mobility decreased, fever, headache and shivering to be related to Shingrix.  Additional case details were reported as follows: The patient got sick and felt  like the flu after receiving Shingrix. The patient could not move the arm it hurt so much, and had fever (101 degree C). The patient also experienced headache and shivering after receiving Shingrix. The patient asked getting a 2nd dose or would all the events get worse.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/3/21 (EN6204) Pfizer Dose 2 3/24/21 (EP6955) COVID Positive 11/21/21  11/21/21: 75-year-old male with obstructive sleep apnea on CPAP, type 2 diabetes mellitus, hyperlipidemia, hypothyroidism and hearing loss presented with congestion and shortness of breath. Patient is very hard of hearing making history taking challenging.   Patient reports symptoms started about 1 week ago with chest congestion associated with shortness of breath, cough, fever, decreased appetite and generalized weakness.  Reportedly wife tested positive for COVID-19, patient is fully vaccinated for COVID x2.  No known or documented immune compromised status.  Patient hypoxic 89% maintaining normal oxygenation on 2 L, unremarkable CMP and CBC.  CT chest showed no pulmonary embolism noted bilateral pneumonia.  11/26/21: Patient is admitted to the hospital, placed on contact and droplet precautions, treated with IV remdesivir, IV antibiotics and the IV dexamethasone. Patient is currently on bronchodilators and Mucinex. Attempted to wean off oxygen.  Patient has remained afebrile and hemodynamically stable.  Inflammatory markers are trending down.  He has completed IV remdesivir and IV antibiotics.  Patient is stable for discharge.  Today prior to discharge oxygen walk test is done to determine the need for home oxygen therapy.  Patient qualifies for home oxygen 3 L by nasal cannula continuous. Findings discussed with the patient and he is agreeable to have home oxygen.  Discussed with care coordination team, oxygen cylinders are being delivered at home, both portable and stationary as patient is mobile.
This spontaneous report was received from an health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of VARIVAX (Merck), Lot # K002929, expiration date: 26-FEB-2016 and Lot # reported as K003409 and expiration date: 06-MAR-2016 (dose and route of administration were not reported). The vaccine was exposed to 17F for 12 hours. It was also reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Localized hives after dose 1 administration; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug allergies or reactions, concurrent conditions, and concomitant drugs were not reported.  On an unspecified date, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis.   On an unspecified date immediately after varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient got localized hives. The outcome of the hives, and the causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and hives were not reported.   This case is non-valid due to the lack of identifiable patient information.
she has a urinary tract infection; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "she has a urinary tract infection"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urinary tract infection.  Additional information: His wife takes warfarin and he is wondering if it's a contraindication with the vaccine. He also mentions that his wife became sick a few days ago, she has a urinary tract infection. She takes Cephalexin 250mg every 6 hours, 4 times a day. She has E.coli bacterial infection in her urinary tract. She started taking it yesterday, 17nov. She will stop taking the medication on 22nov which is the day before the booster shot. He is wondering if that will be a problem with the vaccine (drug interaction). He had called back in March. He explains that both his wife and himself took both doses of the Pfizer BioNTech COVID19 vaccine "under the emergency usage authority". He is calling because he has follow up questions because they are scheduled to take the booster. The appointment for the booster shot is for 23Nov.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to an approximately 9 days old neonate of unknown gender. No pertinent medical history or concurrent conditions were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K024552, 0.5 ml, intramuscularly. No adverse effects were reported. This report was linked to case 1509USA012524 as it was received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting, chills
15 MINUTES AFTER INJECTION PATIENT SARTED COMPLAINING OF LEFT CHEEK SWELLING AND FEELING DIZZINESS AND LIGHTHEADED. GAVE PATIENT A DOSE OF 50 MG DIPHENHYDRAMINE AND A BOTTLE OF WATER. SWELLING WENT AWAY AND PATIENT WAS FEELING BETTER AFTER ADDITIONAL 30 MINUTES OF MONITORING.
sore throat; felt so tired; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported), intramuscular, administered in upper Arm Left on 19Feb2021 12:00 (at the age of 74 years) as dose 1, single for covid-19 immunization. There were no concomitant medications and medical history. Patient had no prior vaccinations within 4 weeks. On 19Feb2021, the patient experienced felt so tired, on 22Feb2021, patient had sore throat and on an unknown date fell asleep. Patient had to go an hour and half to go get the vaccine. He got pretty tired driving home. He took a nap as soon as he got home. The next day, he became very tired. He was in fact so tired, he fell asleep while on a phone call with his friend. His wife asked him did he hear the question his friend was asking on the phone and the caller explained that he didn't answer the question because he was asleep. The tiredness was the first major side effect. The patient had the vaccine on a Friday. By Monday night, he was helping a friend out and as he was driving back home, he started having a sore throat that was like in the back of his neck. He did gargle some salt water. He mentioned that his son got COVID and he knows that a sore throat was his first symptom. However he has not seen his son in 4 months, so he knows that it wasn't from his son. The nurse he spoke to, she said it could be a possible side effect from the vaccine. He had no fever, or anything. On the same day he received the vaccine, he did get a Rapid COVID test and a PCR test and both came back negative. He needed to have the testing done to visit someone. He did not think he still has the tiredness. The tiredness was very strong the first 2 days. He could sleep easily no matter what, so he doesn't believe its still an issue. The sore throat lasted about a day and half until Wednesday. He clarifies he hasn't recovered completely, he believes he still has a little residual. However, he tends to be a nervous guy, so it could just be a memory of that. Clinical outcome of the event felt so tired was reported as unknown and recovering for sore throat.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Neck swollen; Neck hurting; Heart palpitation; feeling weird; felt like she was going to faint/Light headed; Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Thyroid disorder.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed), BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit) and PALPITATIONS (Heart palpitation). On 03-Mar-2021, the patient experienced SWELLING (Neck swollen) and NECK PAIN (Neck hurting). At the time of the report, FEELING ABNORMAL (feeling weird), DIZZINESS (felt like she was going to faint/Light headed) and PALPITATIONS (Heart palpitation) had resolved and BURNING SENSATION (Glands in the right/left  jaw were burning a little bit/Glands in the left jaw were burning a little bit), SWELLING (Neck swollen) and NECK PAIN (Neck hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information received on 11-MAY-2021, TCR added but NNI updated
LD area reddened/warm to touch-skin taut; no pain; t99.4;
Chills; fatigue; weakness; lymph nodes full/swollen; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 at 15:00 as a single dose for COVID-19 immunization (at the age of 29-year-old). The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunization (at the age of 29-year-old). No other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior vaccination and not tested for COVID post vaccination. On 24Mar2021 at 05:30, the patient experienced chills, fatigue, weakness and lymph nodes full/swollen. No treatment was received for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client seen and assessed by EMT.  A series of vitals: BP 90/20, HR 43, (2nd), BP 118/90, HR 64, O2 92.  (3rd)108/84, HR 60, O2 90,  Client advised to go to ER by paramedic. Client's daughter voiced that she will take her mom to ER herself.  After 3rd vital assessment was taken client states that she will call her primary Dr. and inform her about the reaction and will follow up with what ever MD advises. Client cleared to go home by EMT.
Dose Booster given to early 1st dose: 12/01/2021, 2nd dose: 01/25/2022, 3rd dose/Booster: 03/01/2022
The afternoon before my symptoms occured, I felt a sensation as if someone put an electrode into my right sinus cavity and zapped me.  Next day, August 25, 2021, I woke up, exhausted, with a horrible and uncontrolable sinus heache, sneezing, runnying nose and watery eyes. I took Mucinex DM and had a PCR rapid covid test on Friday, 8/27/21(from my Dr.). dr. told me to stop Mucinex and to take alternating doses of Tylenol and Ibuprofin every six hours.  This did not help my headache at all. Lost taste and smell senses on September 1, 2021.Symptom free on 9/5/2021. On 9/6/2021 severe abdominal pain; CT scan on 9/7/21 dx'd covid related diverticulitis.My taste has returned; however, I still can not smell.
develops symptomatic covid; develops symptomatic covid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, 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. The patient developed symptomatic Covid on an unspecified date. The patient received dose #1 of a Covid-19 vaccine and contracted Covid-19 prior to dose #2. The patient underwent lab test which included Covid-19 test in which he/she developed a symptomatic Covid-19 on an unknown date. Outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021014755 Same reporter/drug/event, different patient
Soreness at sight of shot; progressed to significant swelling, red streak down arm, headache, all-over not feeling well.
Pt reports that the same day of her vaccination, she developed arm soreness (common  side effect), then 2-3 days later she developed additional left arm soreness with a new rash on her left hand that then spread to both her forearms, inner thighs, lower legs and abdomen. They were fixed skin lesions that scale, rather than hives, and did not clear with anti-itch medication (Hydrocortisone topical cream 3x daily for 1 week, or Hydroxizine oral medication q8yrs as needed).   Presumed diagnosis based on rash appearance was Pitryiasis Rosea and has since been following this rash pattern or slowly improving over time
Received PCV-13 vaccine at 3pm on 11/4/16. At 8pm same day experienced mild pain and swelling at injection site. At 3am next day woke up with 10/10 pain, fever 102.2 F. On 11/5 temp max was 104. Took ibuprofen and acetaminophen with good effect. Had abdominal cramping 11/5/16. Fever and abd. cramping resolved 11/5. Continuous site swelling and pain 11/7.
Patient called in mid December reporting pain at the injection site.  She also reports shoulder pain unassociated. This has not been ongoing since the time of administration.
Arm was Itching; Red around site; Sore for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days). At the time of the report, VACCINATION SITE PRURITUS (Arm was Itching), VACCINATION SITE ERYTHEMA (Red around site) and VACCINATION SITE PAIN (Sore for a couple days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.