chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saw two lumps in armpit and thinks they are lymph nodes; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 62 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:10 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing. Grandmother dies of breast cancer and mother dies from lung cancer. Patient states that she is on 2 different types of cholesterol medications. Concomitant medication(s) included SIMVASTATIN taken for blood cholesterol increased, start and stop date were not reported. The patient experienced two lumps in armpit and thinks they are lymph nodes as axillary mass on 25Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included mammogram: normal.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained..
She got her vaccine, she had no problems.  On 5/12/21 she developed a rash that started on her stomach.  The day before she did ran.  The rash traveled up her torso toward her neck, developed blisters everywhere and within 3 days her body was covered with the rash and still has residual marks on her skin from this.  She also has residual marks on her leg where she was running ointments for the itch, and developed a bruise and now the blood vessels are showing through her skin.  She also had purple legs where she had to get her blood moving and had to exercise immediately to get blood flow back to her legs.  She went to the UC on 5/14/21, and they gave her steroids, and sent her home with Methyl  Prednisolone, Cetirizine HCL 10 mg tablets #7, Famotidine 40 mg #7.   He wanted to send her to the ER for IV steroids as the rash was so severe, but she did not go there.  They gave her a shot of Benadryl as well.  The rash and itching have subsided but it did not subside until about 2 days ago and now has the residual markings from the rashes themselves.   She does have pictures to send if necessary.
No additional adverse effects reported and; Caller who is a Nurse, inquiring about recommendation for PROQUAD that was inadvertently given to a coworker over the age limit according to PI.; The coworker was supposed to get MMR and V ARlV AX separately; This spontaneous report has been received from a nurse, referring to a patient of unknown age, who was 47 years old. Information about the patient's pertinent medical history, concurrent conditions concomitant medications and previous drug reactions and allergies was not provided.  On 27-JUL-2021, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milligram, lot number T032147 and expiration date on 20-MAR-2022  for prophylaxis (frequency, route of administration, anatomical location were not provided) to a coworker over the age limit according to the product information (product administered to patient of inappropriate age). The coworker was supposed to get Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) separately (wrong product administered). No additional adverse effects reported.
lethargic; hungry; fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HUNGER (hungry) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic), HUNGER (hungry) and PYREXIA (fever). At the time of the report, LETHARGY (lethargic), HUNGER (hungry) and PYREXIA (fever) outcome was unknown.
while it was administered, the syringe came off the needle and some of the dose ran down the arm; syringe came off the needle and some of the dose ran down the arm; A spontaneous report  was received from a Health Professional concerning patient who was administered Moderna's COVID-19 vaccine.  The patient medical history was not included. Patient concomitant was not included  On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: Unknown) prophylaxis of COVID- 19 infection.  Pharmacist states a patient received the second dose of the Moderna Covid-19 vaccine and while it was being administered, the syringe came off the needle and some of the dose ran down the arm. Don't know how much of the vaccine the patient received and wants to know if and when they should receive another dose.  Treatment of these event (s) were not provided.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported; Reporter's Comments: This report refers to a case of device connection issue, and underdose for mRNA-1273 with no associated AEs.
Extreme nausea, headache, and fatigue, persisting from 30 hour post-injection until ~90 hours post-injection. This was accompanied by intermittent diarrhea and vomiting.  The level of nausea and headache were debilitating and required full cessation of all ordinary life activities.
Information has been received from a health professional concerning a 13 year old male patient who on 11/30/1998 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/22/2004, the patient developed breakthrough chickenpox with 50 to 500 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 6/28/21 (lot NA) Pfizer Dose 2 7/19/21 (lot NA) COVID Positive 12/30/21  12/30/21: Patient is 44-year-old female with past medical history of bronchial asthma, hypertension, bipolar disorder and catatonia.  She is being transferred from facility for further management of COVID-19 infection.  Patient was admitted to hospital on 12/16/2021 and has been managed for bipolar disorder, catheter and altered mental status since. Earlier this morning, patient was noted to be having nausea, vomiting and load grade fever with T-max 100.2° F. she underwent multiple workups for fever including nasopharyngeal swab for COVID-19 which came back positive. Patient is being transferred to hospital for further management of COVID-19 infection.  Patient reported upper respiratory tract infection symptoms including sore throat and runny nose since yesterday.  She reported intermittent low-grade fever.  She reported dry cough.  No shortness of breath, chest pain or palpitations.  No nausea vomiting or abdominal pain.  Patient reported being fully vaccinated for COVID-19.  She denied use of tobacco products.  Per psych team, patient has been responding to treatment of her psych issues and was scheduled to be discharged home in the next 1-2 days.  Upon review of vital signs.  Patient is hemodynamically stable and maintaining saturation on room air.  She is tachycardic.  Lab work is unremarkable except positive nasopharyngeal swab for COVID-19 infection.  12/31/21: Patient is a 44-year-old female with past medical history of bronchial asthma, hypertension, bipolar disorder and catatonia.  She is being transferred from facility for further management of COVID-19 infection.  Patient was admitted to hospital on 12/16/2021 and has been managed for bipolar disorder, catheter and altered mental status since.  Patient started having nausea, vomiting and low-grade fever.  Patient is a positive COVID-19.  Chest x-ray is negative.  Patient has remained afebrile.  Patient is on room air.  Patient's time p.o. intake.  Can continue antiemetics.  Patient stable to be transferred back to facility.
Client vaccinated with 2nd dose Moderna on 02/10/2021; 2nd dose was due on 02/18/2021. Client vaccinated 1-week earlier. Mother upset because her daughter would not get vaccinated with 2nd dose. We explained it was too soon to vaccinate; due date is 02/18/2021.
patient was sent to the emergency room last evening after acute seizure activity--- apparently he had complained earlier on 10/28 of weak/lethargic.symptoms, but had only consumed one cup of water so far when seen, thus was discharged back to the block and encourage to increase fluid intake   As the ER report is not yet back, this provider spoke with the doctor from the hospital at 10:40 this a.m.-- the patient stated to the ER staff (& to this provider) that he had gone out previously for seizure activity after a Covid vaccine, however, he is apparently confused because he was sent out August 2020 for seizure activity and did not receive a Covid vaccine until 4/7/2021---he was seen on 4/8/2021 for complaints of shortness of breath and weakness, but did not have any reported seizure activity at that time. While at the ER last evening, the patient had a Keppra level drawn, which is still pending, and was given a 1 g dose of Keppra IV and subsequently returned where he was admitted to the infirmary. He denies any complaints at this time
pt had 4 staring episodes, lasting 3-5sec each, during which pt was unresponsive to voice of caregiver;pt had no fever or other sx;
not feeling well after their first dose; Fever; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program.   A patient of an unspecified age and gender received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the shot on 31Mar2021 so they were just 'in spite' not feeling good for 3 days, fever and all that kind of stuff it was not a reaction or anything. It was a common side effect so they didn't get the shot. Now they want to get the second shot now so just want to make sure that it was okay. The outcome of the event not feeling well' was recovered. The outcome of event fever' was unknown.   The information about lot number has been requested.
splitting headache; chills; nausea; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain). At the time of the report, HEADACHE (splitting headache), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .   This case was linked to MOD-2021-214773 (Patient Link).
This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 03-Oct-2017, concerning a patient of an unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), batch number: 195227 and expiry date: 31-May 2018, PTC number: 1025025, route of administration and anatomical location: not reported). On 28-Sep-2017, while administrating the vaccine, the needle of the syringe was screwed to give the shot the Lori lock came apart, the needle and Lori lock ends up stuck in the patient's arm and it sprayed all over the skin (explicitly considered as syringe issue). The patient received partial dose (explicitly considered as under dose). As per the PTC (product technical complaint) report, no damage was in the package condition or in the syringe (25 gauge, no signs of leakage), but broke when needle was inserted as the hub was loose. It was reported that, the product was stored in the original box until use and placed in a refrigerator. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for syringes for luer lock separation during administration. The most likely root cause can be attributed to improper handling by the user. The reporter assessed this case as non-serious. non-significant case correction received on 03-Oct-2017: The PTC (product technical complaint) reference number (1025025) was updated. Follow-up report received from QA investigation on 16-Nov-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No Internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017-2018 FLUCELVAX Commercial Season for syringes for luer lock separation during administration. The most likely root cause can be attributed to improper handling by the user. Expiry date was updated to 31-may-2018. Amended narrative accordingly.
p/ pt recv vax approx 1yr later pt devel breakthrough chickenpox, pt had 15-20 lesions on body
The patient stated that the morning after her vaccination her arm was so stiff and painful she could not raise it above her head. By the following morning it was still sore, but she could raise it above her head. She also reports significant fatigue, loss of appetite, and moderate nausea the day following the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Gabapentin, reaction(s): "Known allergies: Gabapentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (27Apr2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (27Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Apr2023 to 25Apr2023. Clinical course: Patient was not taking any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182804 same patient, different product and event;
Approx 4-5 hours post vaccination pt started a systemic allergic reaction that has progressed to require steriods and she had two episodes of SOB and tongue swelling that have resolved but are worsening in severity.
nauseous; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced nauseous on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SVT in right calf  Missed menses after vaccination (October, November 2022  & February 2023); patient is not sexually active with no risk of pregnancy
Autistic mannerisms, system "shutdown". Blank stares, catatonic state.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 12-AUG-2014 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX that had been stored at 39 degrees F for 14.5 hours, subcutaneous (lot#, strength, frequency unspecified). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a physician refers to a 23 years old female patient. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) on 18-JAN-2008 and received the second dose of GARDASIL (Lot # not reported) on 20-MAR-2008. The patient was receiving her third dose of GARDASIL (Lot # not reported) on 26-JUL-2012. No adverse effect was observed or reported. Additional information has been requested.
On September 16, 2019 I took my son, Patient to his 15 month check up. He received a DTaP shot at about 11:30am, we got home maybe 20-30 minutes later where I stood him in our living room and got settled. At about 12:00pm he started crying inconsolably, but wouldn?t move.  I said, ?come here,? but he just stood there, cries turning to screams. I grab his hand to get him to walk closer, but he falls over and does not get up.  I pick him up, trying to calm him, but he?s still crying uncontrollably.  I try to stand him in my lap, but he feels limp. I check everything on him, making sure he?s okay, seeing what I can do to help, nothing helps.  I have no clue what?s going on or how to help, so I call the doctors office - I can only hear some of what they are saying, but I try to tell the nurse what?s going on while he cries in the background, the nurse told me that soreness is to be expected and to give some Tylenol.  We?ve had shots before, but never any of this. Never crying like this, never going limp like this.  I finally calm him down and get him to sleep long enough for my husband to come home.  After weeks/months of research, talking to a family friend who had knowledge in this area, and a few nurse friends, I was able to discover that this was a hypotonic hypersensitive episode.   That afternoon and the following few days of that week, it?s as if Patient was re-learning how to walk. He was 15 months and had started walking at 11 months, so this was not a difficult task for him, but he was very clumsy, would stumble and fall several times a day. My husband and I both made comments to each other about him being very clumsy.  Patient also had/has a speech regression/delay which I am confident came after this. I only say this because I spent every day with him before and after and watched the regression and these are the things that I witnessed.  - Patient had been saying: Mama, Dada, Nose, Hair, had been practicing feeding himself, and when asked would point to a body part.  - 09/14/2019 he said ?sit down? his first 2 word sentence ever, (I was so proud, I documented it!) After his shot, he did not say the above words again until just a few months ago after months of speech therapy.  When I asked if he wanted to hold a utensil to help feed himself, he would act as if he were throwing a tantrum.  When his toys (that he has played with for months) would make a noise, he would flinch, when prior to the shot, he never did this.  He did not point to his body parts again for months as well, until speech therapy and months of me working with him again.   A few treatments that have helped are, of course, speech therapy (he began this in maybe February) and glutathione cream.  His doctor now has been amazing and very supportive and has said that he?s improved so much.
Information has been received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition, drug reactions and concomitant therapy were not reported. The reporter reported that an unspecified number of doses of improperly stored VARIVAX (Merck) (dose and route were not reported) were inadvertently administered to an unspecified number of unspecified patients since 17-SEP-2015. No adverse effects have been reported. Additional information has been requested. Lot number L015433 is an invalid lot number for VARIVAX (Merck).
possible fever, not measured, felt bad; sore arm 2 1/2 indurated, erythematous area above & below inject site;
Initial pregnancy report received from a healthcare professional on 08 May 2013. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose 1 of ADACEL vaccine lot number: C4366AA in right deltoid on 08 May 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 21 September 2012 and the expected date of delivery is 03 July 2013. List of documents held by the sender: none.
patient was administered Moderna vaccine while temperature excursion assessment was ongoing; patient was administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medications were reported.