chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse regarding 4 year old male patient. The patient's medical history included Austism spectrum disorder ( reported as "autism"); no concomitant medications were mentioned. On 27-OCT-2017, the patient was administered a dose of PROQUAD (lot number N015624, expiration date 27-OCT-2017), subcutaneously as a prophylactic treatment. The vaccine was reconstituted with QUADRACEL DTAP instead of intended sterile diluent (product preparation error). The patient's physician was notified of the procedure by the nurse (vaccine provider), as well as both vaccine companies and the patient's mother. The reporter stated that there was no adverse reaction noticed in the patient; therefore, no adverse effects were reported. She also said there was "no bad outcome from this" and considered the report to be non-serious. No PQC was mentioned in the report.
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 003C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Date vaccine stored in Standard Freezer on 22-Apr-2021. No treatment medications were reported. This case contains 20th patient information out of 45 patients.
The shot itself was injected very high into my left arm, just at the tip of my shoulder. By the end of the day, my upper back and neck became very stiff  and it hurt to sleep n that side or move it for a couple days . Five days after the shot, I began to experienced constant ringing in my ears - tinnitus. It has not stopped
Rectal bleeding; Vomiting blood; A spontaneous report was received from an 84-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced rectal bleeding and vomited blood.  The patient's medical history was not reported. No concomitant medications were reported.  On 11 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 012L20A) intramuscularly, for the prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced rectal bleeding and vomited blood.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, rectal bleeding and vomited blood were considered resolved on 11 Jan 2021.; Reporter's Comments: This case concerns an 84-year-old female patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Rectal bleeding and Vomited blood the same day after receiving their first of two planned doses of mRNA-1273 (Lot 012L20A). Treatment information is not provided. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Fever for about three days at 102.5-8 degrees F, sore throat phlegm, achy all over. Started to feel better on 01/24/2014.
About 20 minutes after receiving second dose of Moderna COVID-19 vaccine (Lot# 013L20A), pt reports tingling in mouth and subjective sensation of tongue "swollen".  Assessed by NP - no changes noted on tongue/uvula.  Pt declines antihistamine due to concern for drowsiness.  She reports a h/o allergies to ciprofloxacin and sulfa antibiotic.  Observed for additional 30 minutes w/ no additional s/sx.  Pt aware to contact emergency services if any changes develops.  Left ambulatory in NAD.
Reporting a Paxlovid Rebound: On 15Aug tested positive again & on 16Aug symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug & 19Aug.; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 15Aug2022, outcome "unknown", described as "Reporting a Paxlovid Rebound: On 15Aug tested positive again & on 16Aug symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug & 19Aug.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive; (10Aug2022) Negative; (13Aug2022) Negative; (15Aug2022) Positive; (16Aug2022) Positive; (19Aug2022) Positive; (22Aug2022) Negative; (25Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Patient was double boosted & take precautions for Covid19 exposure. Tested positive for Covid19 on 05Aug2022 & began Paxlovid same day. By 09Aug2022 symptoms had resolved. Tested negative on 10Aug2022 and 13Aug2022. Reporting a Paxlovid Rebound: On 15Aug2022 tested positive again & on 16Aug2022 symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug2022 & 19Aug2022. By 22Aug2022 symptoms began to lessen & tested negative. Tested negative again 25Aug2022.   No follow-up attempts are possible. No further information is expected.
Experienced a swollen lymph gland in her armpit on the side of where she received the vaccine which is her left side; tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 12:00 (Lot number: ER8729, Expiration Date: 14Apr2021) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial hysterectomy" (not ongoing). Concomitant medication(s) included: ESTRADIOL taken for hysterectomy. Vaccination history included: Bnt162b2 (Dose 1 single, at 09:30am, lot- EN6207, Expiry date- 31Jul2021,), administration date: 20Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "recovering", described as "Experienced a swollen lymph gland in her armpit on the side of where she received the vaccine which is her left side"; TENDERNESS (non-serious) with onset Apr2021, outcome "unknown", described as "tenderness". Therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: Patient had no Prior vaccinations within 4 weeks. The patient did take an anti-inflammatory medication she had on hand and it seemed to help and was Meloxicam and was a small dose but she does not know the dosage and states it may be 0.15 but she is not sure. she took Estridol and did not know the dose but it was a low dosage and she began taking it probably about 8 years ago for a partial hysterectomy and takes it once per day by mouth.   No follow-up attempts are possible. No further information is expected.
Onset of swelling and pain in both hands, more prominently the left, about a week after injection.  Symptoms are only slightly improved by now despite occupational therapy.  A round of Prednisone worked very well but symptoms resumed after stopping.  Diabetes prevents longer use of Prednisone or any SSRI.
pt was given DTP shot w/a reaction to the pertussis in the shot; no info on the adverse reactions were provided;
Went to hospital for shortness of breath and chest pain after 2nd shot. Nurse had advised me that previous patient had come in with same symptoms as well after vaccine. Drs found no results to cause issues
Severe head ache in the side of his head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe head ache in the side of his head) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Severe head ache in the side of his head). At the time of the report, HEADACHE (Severe head ache in the side of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Acetaminophen; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of mRNA-1273.
Breakthrough case admission after two vaccines Moderna 4/13/21 Lot# 017B21A Moderna 5/11/21 Lot# 040B21A
Grover's disease and flare up on skin got worst; This non-serious case was reported by a physician via call center representative and described the occurrence of condition aggravated in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included grover's disease and skin disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced condition aggravated (Verbatim: Grover's disease and flare up on skin got worst). The outcome of the condition aggravated was not resolved.   It was unknown if the reporter considered the condition aggravated to be related to Shingrix.     It was unknown if the company considered the condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 29-MAR-2023 The dermatologist reported that after Shingrix first dose, a patient with Grover´s disease got worst. There was a flare up on her skin and got worst. No further details such as lot number or Shingrix administration date had been  provided due HCP was on a rush during the call interaction. The reporter consented to follow up via email.
Narrative:  SYMPTOMS ARE IMPROVING BUT CONTINUE TODAY Symptoms:  Headache, Myalgia, Fever, NauseaVomiting & FATIGUE  Treatment:
I had a cold with runny nose, sore throat, and cough. I did not have a fever. I went to the doctor on 09/13/2021. I had a strep test and a COVID-19 test done, and both were negative. They gave me Amoxicillin and now I am all better.
LOST SEVERE AMOUNT BLOOD PLATELETS; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced lost severe amount blood platelets. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost severe amount blood platelets was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Fever over 102, severe headache, muscle aches, extreme fatigue, shivering  over a 5 hour period.  Fever and shivering subside but continue with significant fatigue and muscle aches throughout the rest of the day.  Gradually subsiding next day (day 2).  On day 3, mild fatigue.
Pain at the site with in 5 min of injection then radiated down the arm. Short while after that pain traveled to the other arm & the rest of her body (joint pain) dizziness & HA. Client went to bed at 9:30pm & was feeling much better not 100%. Three other family members received this vaccine at the same time & did not experience any unusual event/ reaction during or after vaccination.
Severe chills, fever, pain at injection site, ears hurt, ears ringing, massive headache, tired, malaise, weakness and sore throat.
Patient reported "throat tightening" and "tingling lips" approximately 15 minutes after receiving the vaccine. Vitals WNL, patient awake, alert, and oriented duration of monitoring. EMTs arrived 8 minutes after they were called, and patient was brought to local hospital for monitoring.
Patient reported her tongue was sore, raw, and painful when she woke up the 2nd day after her 1st dose of Moderna Covid vaccine.  She denied any swelling of the mouth, tongue or throat.  Rinsing with warm salt water did not help.  She said it was slightly worse today than yesterday.
10/31 T 101.5, fussiness, thrashing in the night, alternating with listlessness, Tdap given in error. 11/1 Seen in office, PE: alert, playful. 11/2 8:30 AM PC by health care provider, baby much better.  To be seen by healthcare provider 11/3.
pt recv vax 18JUN97 & the next day pt exp a local rxn;
Developed shingles (VZV PCR (+)) diagnosed 2/29/16. Varicella vaccine administered 12/17/15.
Redness, swelling and itching at injection site. Also experiencing body aches and fatigue. Recommended topical hydrocortisone on irritated site on day 2, and Tylenol for body aches. Outcome unknown.
This spontaneous report as received from a 68 year old female patient, reporting on herself. Her medical history and concurrent conditions were not reported. On 14-APR-2016 (reported as on Thursday), the patient was vaccinated with ZOSTAVAX in unspecified forearm (strength, dose, route and lot number were not reported). Concomitant medications were not reported. On 16-APR-2016 (reported as Saturday), the patient developed a rash around the injection site, the rash looked like a patch and was thick. The patient sought a medical attention via visiting back the physician and received BENADRYL, however, the outcome of injection site rash was unknown. The relatedness between the event and vaccination with ZOSTAVAX was not reported. Additional information is not expected since there was no contact information provided.
side affects made me sick for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The shingles could be the pain but the vaccine was not nice either. The side effects made the patient sick for 24 hours and just thought need 2 vaccines like the covid. The follow up would not possible as no contact details were available.
Information has been received from a health professional concerning a patient (37 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Burning sensation down right arm. Swelling,  stiff and joint pain of right hand, still not resolved. Swell at injection site, pain. Blood pressure fluctuation for 3 weeks. Fainted 3 times 3 hours after first dose. Menstrual cycle longer and heavy flow
24hr p/vax pt had swelling, redness & pain in both inj site;swelling lasted about 4 days;parent appeared cool & warm compresses as advised;today parent states 20SEP that swelling & soreness gone;
This spontaneous report was received from nurse concerning an unspecified number of patients of unknown age and gender. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored Oka/Merck VARIVAX, reported lot number R007695, expiry date 14-MAR-2020 (strength, dose, route and frequency were not reported), LIQUID PEDVAXHIB, reported lot number N034410, expiry date 01-FEB-2020 (strength, dose, route and frequency were not reported), and RECOMBIVAX HB reported lot number N002914, expiry date 04-NOV-2019 (strength, dose, route and frequency were not reported) all vaccines for prophylaxis. The administered dose of LIQUID PEDVAXHIB and RECOMBIVAX HB, experienced a temperature excursion of 47°F to 77°F (52.7°F) for 2 hours, with a previous temperature excursion of 32°F up to 35°F (33.1°F) for 2 hours and 25 minutes. Regarding Oka/Merck VARIVAX, experienced a temperature excursion of 6°F to 14°F (8.8 °F), for 1 hour, with a previous temperature excursion of 6°F to 14°F (6.3 °F) for 10 minutes. It was not recorded by a data logger. No adverse effects were reported.
Feeling very tired; I just sleep more than I normally do; I don't feel right since I have took the vaccine; Feeling very tired/Fatigue; This is a spontaneous report from a non-contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was trying to find out what are side effects of them because since patient had took the vaccine, on an unknown date in 2021, just being feeling very tired and very fatigue and just sleep more than normally does and wanted to find out if that is the part of the side effects and would like to know if people has been calling you to repot this and how long does it last and would like to find out how long does the vaccine is going to effect for because they said 'we don't' took our second vaccine but they are saying something about giving me the booster and patient don't want to get the booster (Further clarification was unknown). Patient don't feel right since have took the vaccine and wanted to know why they wanting to give the third shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient here to have a a Pfizer booster. A Janssen COVID-19 given in error. At first, patient was given 0.3mL of Janssen because it was thought to be the Pfizer vaccine. After consulting MD, an additional 0.2mL was given. Patient aware he received Janssen vaccine booster instead of Pfizer.
Arm became very red, sore and hot.  The redness traveled down her Lt. arm.  She went to her Dr. and he dx. an infection and placed her on antibiotics.  The problem then resolved.
First day rash/ hives and headaches with fatigue Continue to aches, fever, headaches and nauseated
Pt arrived to clinic for Covid-19 Vaccine, first dose. No hx of allergies to food, medicine, or vaccine. Hx of anxiety, no history medication management for anxiety.  Vaccine administered at approximately 1:20pm, pt advised to remain in clinic for routine monitoring for 15 min. RN reports pt appeared anxious prior to vaccine. 1:45 Pt denied signs and symptoms of allergic reaction after receiving Covid vaccine, and was allowed to exit clinic area. Pt left with steady gait, no distress reported.  1:49 Pt returned to clinic, c/o throat and tongue feeling warm, pt appeared anxious and pale. PT placed in seated position RN at pt side.  1:50 J. Staff at pts side. Vitals BP 170/110, HR 121, RR 26, 98% o2. EMS called by RN. Epi pen ready at pts side, no Epi administered at this time.  1:52 Pt continues to present pale, small cough noted, pt denies swelling to throat, reports warm sensation to tongue and throat, ?My tongue and throat feel different.? Noted redness to outer sclera bilaterally.  Speech clear. Sat 98% HR 117 2:10 Vitals: BP 180/100, HR 130, RR 26, 98%, pt pale, speech clear, pt remains alert and oriented. 2:13-EMS arrived, report given to EMS by Pharm, pt remains alert but pale, PT left clinic via gurney with EMS.