chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first vaccine the patient was diagnosed with cancer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (After the first vaccine the patient was diagnosed with cancer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 27-Aug-2021, the patient would get first chemo treatment. The patient's oncologist wants the patient to get the second shot asap before their chemo therapy.  Company comment: Very limited information regarding this event has been provided at this time.  However, considering the pathophysiology of a malignant neoplasm, it's unlikely the reported event is related to Moderna Vaccine. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, considering the pathophysiology of a malignant neoplasm, it's unlikely the reported event is related to Moderna Vaccine. Further information has been requested.
the day after receiving the vaccine my arm swelled at the site, turned red and burned.  8 days later, today, the swelling is more like a lump, bright red and itches.
Taste the medication in her mouth; it was like a tinty taste or metal taste; Burning sensation on tongue; Pain at the injection site; Headache; Chills; Fatigue; Nausea; A spontaneous report was received from a consumer concerning herself of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced taste of the medication in her mouth; it was like a tinty taste or metal taste / dysgeusia, had burning sensation on the tongue / burning sensation, had pain at the injection site / vaccination site pain, headache, chills , fatigue and nausea.  The patient's medical history, as provided by the reporter, included cholesterol. Concomitant medications reported included cholesterol and estrogen medications.  On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) via unknown route for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced event(s), felt the taste of the medication in her mouth; it was like a tinty taste or metal taste, had burning sensation on the tongue, had pain at the injection site, headache, chills , fatigue and nausea. The patient stated that she developed symptoms on the  way home from the hospital where she got the vaccine.   Treatment information included the use of acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.   The event felt the taste of medication in her mouth, it was like a tinty taste or metal taste, got resolved on 01 Mar 2021.  The outcome of event(s), had burning sensation on the tongue, had pain at the injection site, headache, chills, fatigue and nausea was unknown.
known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 24Feb2022, this case now contains all required information to be considered valid.   This is a literature report.  An 89 year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; sars-cov-2 test: positive.  Additional information: We sampled 130 NH residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the NH buildings and medical center who all had access to the same vaccine at the same time as the NH residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 89-year-old female. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event lack of efficacy based on the known safety profile and temporal association ,Linked Report(s) : PFIZER INC-202200381102 Same article/ drug/event and different patient
pt had tongue and facial swelling and hives. Was prescribed Prednisone by another MD.
24 hrs p/inject started itching, then redness (inject 22JUN93) redness swelling whelp 1 inch; DPH; Topicort;
given Johnson and Johnson Covid 19 vaccine after being given 2 doses of the Moderna Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (given Johnson and Johnson Covid 19 vaccine after being given 2 doses of the Moderna Covid-19) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hepatitis in February 2017. Concurrent medical conditions included Hypertension, Asthma and Tachycardia. Concomitant products included LEVALBUTEROL [LEVOSALBUTAMOL] for Asthma, HYDROCHLOROTHIAZIDE for Hypertension.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (given Johnson and Johnson Covid 19 vaccine after being given 2 doses of the Moderna Covid-19). On 20-May-2021, INCORRECT DOSE ADMINISTERED (given Johnson and Johnson Covid 19 vaccine after being given 2 doses of the Moderna Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received: Patient demographics, medical history and concomitants were added.
mom states pt creid unconsolably 3hrs p/last vax given 12MAY95 also had colic @ this time; mom unsure if was d/t colic or vax; 26JUL95 TC to MD order give ped DT no problem
The patients left arm bicep area became inflamed red and itching with a red rash around 5:15am this morning... it has slowly since began to subside with no other pain or itching occurring at time of visit to pharmacy 11:55a.  At presentation patients arm was still red and slightly swollen but no longer uncomfortable.  The patient experienced NO respiratory side effects.
Fever, body aches, head ache, pain and swelling at injection site,  extreme tiredness that lasted for several days
Within 3 hours I started to have a headache, achy muscles, fatigue, achy joints, nausea and moderate pain at injection site. This went on for 4 days. I was weak and the HA came and went. I had a similar reaction to the first shot in the series but not as severe. Only 2 days of these symptoms, I never react to shots in the past.
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) 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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 11th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Headache, UrticariaPruritus, Sore arm x 4 days Narrative:
PATIENT BECAME DIZZY, LIGHTHEADED AND PALE. PATIENT LAYED IN SUPINE POSTION AND GIVEN FOOD. BP OF 99/69, HR 72, O2 100% RA BS 159. CALLED 911- PATIENT REFUSED TRANSPORT. PATIENT MONITORED AN ADDITIONAL 15 MINS WITHOUT ANY PROBLEMS. ALL SYMPTOMS RESOLVED.
Patient came in forher first dose of the Moderan vaccine.  Patient is an overnight associate.  We processed her paperwork, I asked her if she felt ok (answered the questions she had fiklled out) and then I proceeded to have her sit in the booth.  When I went into the booth, I explained to her when her second dose was and to bring back her vaccine card.  She stated she did not really want to get the shot, but was being pressured by her mom.  I asked her if she was sure she wanted the shot, and she said yes because her dad has a heart condition.  I then proceeded to administer the shot at 8:12 am.  She did very well with the shot- no bleeding in the bandaid. I asked her to sit for about 10 minutes.  I proceeded to walk back into the pharmacy, and I dispoded of the gloves.  I then walked over to my computer, then I heard the loud thump at 8:14 am.  I immedietly ran out to the booth and she had fallen over.  We called a code white and called 911.  Pt was awake, hit her head and mouth. I asked her if she had eaten and she said she could not remember,  She said the shot was fine and she was on her phone and that is all she remembers.  I rubber her back and chatted with her until the fire department arrived.  She was able to call her cousin from her phone, but I did not move her until the fire department came.  EMS came and she went with them. EMS stated that she had not slept in 24 hours and  that could be the cause.  The time from the shot to the thump was no more than 1 minute.
This non-serious spontaneous case, was initially received on 14-Sep-2017 from other Health Professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, no adverse event was experienced by the patient after second excursion of the vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up report received on 20-Sep-2017: New event (no adverse event) was added. It was reported that, no adverse event was experienced by the patient after second excursion of the vaccine administered. The narrative was amended accordingly. Non-significant case correction received with IRD 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
fatigue, congestion, postnasal drip, rhinorrhea, sinus pressure and sinus pain.
hours after receiving 2nd dose fever, chills ,HA, arthralgia, myalgia fatigue diarrhea continued  thru 2/24/21
I have been suffering fron a Pfizer vaccine reaction for about a month and it does not seem to go away.  I went to the doctor a week after the Pfizer 2nd dose and he told me to take Benadryl. I did and it went away for a few days but it came back after a week. I have had hives on my chest and underarms  for about two weks now. Today, I have a hives again and my upper lip is swollen.  Where should  I go for something like this?  I was vaccinated at a pharmacy with my second dose about a month ago. I am 64 and I think I had an anaphilactic reaction to shrimp about 38 years ago.        Thank you,
This case was reported in a literature article and described the occurrence of anaphylaxis in an adult female subject who was vaccinated with HPV vaccine (manufacturer unspecified). Concurrent medical conditions included asthma. On an unspecified date the subject received unspecified dose of HPV vaccine (unknown route, unknown lot number). 1 hour after vaccination with HPV vaccine, the subject experienced anaphylaxis, abdominal pain, feeling hot, flushing, throat tightness, diffuse itching, shortness of breath, wheezing and sinus tachycardia. This case was assessed as medically serious by GSK. The subject was treated with Epinephrine, diphenhydramine and methylprednisolone. At the time of reporting the events were resolved. The Program was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries. Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. in 2009, the Program charged an institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the table could be updated. Concurrent with the institute's review, the author undertook a systematic analysis of the Program's anaphylaxis case experiences. The Program administrative database was queried for all cases submitted to the Program alleging anaphylaxis or anaphylactic shock for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major or minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current table. This case was classified at level 2 of certainty. This review represented the first systematic approach in analyzing the Program experience with anaphylaxis and will be useful when the table is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
This spontaneous report was received from a medical assistant regarding a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 28-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a female nurse practitioner of unknown age via a field representative refers to herself. The patient's medical history included "repeated" sinusitis. The patient said her physician (unspecified by reporter) recommended that since she was younger than 65 years of age and had "repeated" sinusitis, she needed to get vaccinated with PNEUMOVAX 23. In October 2007 the patient was vaccinated with PNEUMOVAX 23 (dose, lot# and route not specified). After receiving PNEUMOVAX 23, the patient experienced injection site reactions on the same day that she got vaccinated. The patient had cellulitis and there was redness and tenderness at the injection site. The patient's arm was swollen from the "upper portion" to the elbow of that same arm. The patient did not seek medical attention, instead she gave herself ibuprofen, TYLENOL and a warm compress as treatment. The outcome of the events was not reported. The causality was not provided. Additional information has been requested.
On 11-15 the nurse on the I.M.U. floor administered a flu and pneumonia shots to my left upper arm. That night I awoke to a very swollen, hot, red arm. Unable to use the arm for 4 days and it stayed red, swollen for 4 days.
Menactra on 08Oct2021 and Menveo on 18Aug2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva675a, expiry date 31st March 2023) for prophylaxis.   Previously administered products included Menactra (received on 8th October 2021).   On 19th August 2022, the patient received Menveo. On 19th August 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022.  Reporter's Comments: Medical assistance reported that a patient who was vaccinated with Menactra received additional dose of Menveo on the day of reporting.  No adverse event was reported The consent to follow up was granted. Additional Supportive Information: As per schedule only single dose should have been administered, patient had received Menveo post Menactra, which led to extra dose administered.
Chills that evening, took Ibuprofen, Went to bed with headache, woke up in sweat about 3:00 AM, took Ibuprofen, Got up about 8 AM with headache, weak & dizzy. took Ibuprofen,  Went back to bed about 9 AM for 3 hours got up at 12 noon  took Ibuprofen feeling better. Rested rest of day, next day arm  that got shot very sore as to be expected.
Pt experienced an unwitnessed syncopal episode after first dose of Pfizer vaccine. After regaining consciousness pt produced small amount of emesis. Vitals were all within normal limits. Pt refused transport AMA.
Patient weak when driving home after vaccination.  Advised Patient to lay with feet raised and to seek medical attention if no improvement.  Contacted Patient Spouse and she stated patient is doing fine.. today.
On 2/18/2021 the resident spiked a fever of 101.7 and had decrease oxygen saturation down to 86% with a cough. The resident was transferred to the ER for evaluation.  Per Advanced Directives resident was not treated with antibiotics and returned to the Nursing Home on 2/19/2021.  The resident had several episodes of emesis and was placed on comfort measures. He dised on 2/25/2021.
They got sick after first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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: ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "They got sick after first dose".  Additional information: Reporter reported that reschedule appointment for second dose to 28Apr2021 per notice received from vaccination provider. Caller advised they "got sick" after first dose of vaccine 06Apr2021 and questioning whether or not to get second dose. Read FAQ. Declined transfer to Sheet/faxed for AE - side effects/second dose appointment beyond 21 days  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.