chrisvoncsefalvay/vaers-outcomes huggingface dataset:
needle was removed from arm, blood streamed down her arm about 5-6 inches; This is a spontaneous report from a contactable consumer (husband reporting for wife). This 68-year-old female patient female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6201, unspecified route in arm on 09Feb2021 as single dose (at the age of 68 years) for Covid-19 Immunization.  No medical history reported, and no concomitant medication reported.  Historical vaccine included BNT162B2 for Covid-19 Immunization.  The patients husband reported when the needle was removed from his wife's arm, blood streamed down her arm about 5-6 inches on 09Feb2021.  The doctor who removed the needle immediately put a round bandage on the injection site and then the stream stopped but before there was a steady stream of blood running down her arm.  Patient's husband is wondering if she could have lost any of the vaccine when this happened. The caller would like to know if there is any possibility the vaccine might have come out in the blood.  Patient's husband heard the first dose given in (name of city) had leaking from the syringe prior to injection and was an invalid dose.  Patients husband reported "the doctor who did the vaccine did put the needle all the way in and pushed the plunger all the way in." Patient's husband is wondering about how much vaccine is remaining for his protection and the potential need for revaccination.  Outcome of event needle was removed from arm, blood streamed down her arm about 5-6 inches was unknown.
Patient received the flu vaccine yesterday around 3:30pm . she  felt  fine after  getting it  except  her arm felt  a little sore. around 8 pm patient  went  on a walk with mom and started to feel a  little "chiiled"   a little later  she had a mild headache. when she got home she had  to go to the bathroom and when she  got up from the toilet she started to see dark spots both eyes and darkness in her lateral vision bilaterally.  Because of this , and she had never experienced this before, he  called out to her mom.  Dad heard her and  went to go see what was going on. He states when he saw her  she  was pale and looked a little dazed .   She then proceeeded to fall into his arms and  he  took her to the couch .  the episode lasted  very  briefly  and there was  no seizure like activity .  she  was a  little  anxious after the episode and  states  she  had a little dyspnea - dad  states she  was  anxious and  breathign fast  but no trouble breathign . when she calmed down she  then felt  fine and was back to her nml self .
patient was administered with expired TENIVAC with no reported adverse event; Initial information received on 21-Jan-2022 (Non-case) and follow up on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 62 years old female patient where patient was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U6831AA/U7189AA and expiration date- 30-Sep-2023) via intramuscular route in the right arm (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Additional information was received on 05-Oct-2023 from Other healthcare professional: Case was updated from Non case to valid case.
developing severe jaw pain; nervous; It is still very sore top to legs, in groin area; Lymph nodes and top to legs are still throbbing; Could not even open jaw; Lymph nodes and top to legs are still throbbing; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for covid-19 immunization, paracetamol (TYLENOL EXTRA STRENGTH, Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date to an unspecified date, at 1000 mg for jaw pain. Medical history included Follicular Cancer, Spinal issues, back pain, non-Hodgkin's Lymphoma, Treatment was started in May2018 and it was finished in August2019. Concomitant medications included zolpidem tartrate (AMBIEN) Tablet, 10 mg in evening, orally taken for pain, rituximab taken for Follicular Cancer an unspecified indication, bendamustine taken for Follicular Cancer. On an unspecified date, the patient experienced developing severe jaw pain, nervous, it is still very sore top to legs, in groin area, lymph nodes and top to legs are still throbbing, could not even open jaw. The patient developed severe jaw pain, about 2 days afterward. She stated that the situation was very scary for her, she didn't know what was going on. She said that the pain "goes away and sometimes comes back". When probed for the outcome of the event she stated, it was still sore but it's better. But it is still very sore. In her top to her legs, in groin area. She was nervous about receiving her second dose as scheduled, tomorrow, Tuesday, she due to get her second shot and she was not quite sure if she should get that shot. And so she was wondering if anybody had that kind of reaction to the first shot. She was nervous, it was still very sore top to legs, in groin area, lymph nodes and top to legs were still throbbing. No lab work done. The patient reported date of vaccination as "I think it was on 9Mar2021". Treatment received with amoxicillin and Tylenol 1000 mg for jaw pain but it did not help, and treatment received with Tylenol for pain in extremity (reported as very sore top to legs, in groin area), pain (reported as Lymph nodes and top to legs were still throbbing). Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse (L.P.N) concerning a 7-year-old female child, who on 25-FEB-2000 was vaccinated with a first dose of Varivax (lot# 631065/0445J). On 06-APR-2006 the patient was examined by a physician and diagnosed with chickenpox. No outcome was reported. Additional information has been requested.
Patient called the pharmacy and stated that they were fine the night of the receiving the shot, however upon awakening the patient stated that they had severe pain in one foot as well as swelling. The patient then stated that the pain and swelling seemed to be spreading up the leg. The patient was referred the the emergency room with pending outcome.
tiredness/chill; tiredness/chill; left lymph node in jaw swollen; couldnt bite or chew on left side; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) intramuscularly on left arm on 12Mar2021 15:00 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8734) intramuscularly on left arm on 02Apr2021 15:50 as single dose for COVID-19 immunisation. The patient medical history included history included anticoagulant therapy, gastro oesophageal reflux disease, blood cholesterol abnormal and blood pressure abnormal. The patient concomitant medications included Eliquis for blood thinner from 15Apr2020 (ongoing), Omeprazole-DR 20mg for acid reflux from 12Dec2020 (ongoing), Atorvastatin for cholesterol from 15Apr2020 (ongoing), Lisinopril for blood pressure from 2018 (ongoing). On 16Mar2021 at about 07:00 hours, she had her left lymph node in jaw swollen and could not bite or chew on left side. On 03Apr2021 about at about 14:00 hours, she had tiredness/chill. She states that she was on blood thinners and takes Eliquis and no one asked her at the vaccination site. She did not know if that was a complicated adverse event and did not tell them and would like to know why it was mentioned in the factsheet and if there was something she should be looking out for. Treated with Tylenol and clod compress had eased. No relevant tests were done. No Adverse reaction to vaccine from Eliquis. No prior vaccinations. Outcome was recovering for left lymph node in jaw swollen and could not bite or chew on left side and recovered for tiredness/chill.  Follow-up (12Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program.  Information on lot number/batch number has been requested.  Follow up (13Apr2021): This is a follow-up spontaneous report from a contactable consumer which included information on dose, start dates, route of administration, concomitant medications and adverse events.  No follow-up attempts are possible. No further information is expected.
Developed Large local reaction at vaccine site. Induration from shoulder to below elbow, almost circumferential around upper arm. Induration resolved within two days of treatment with prednisone. No systemic symptoms. pt recovered uneventfully.
Pt husband states a patchy rash started on her body a few days after receiving vaccine. Was going to dr on 6/26/18.
Low oxygen/turning gray , elevated bp 1) 139/124 pulse 87, 2) 137/74 pulse 72 nonresponding , shadow breath, seizure/jerking symdrome,
Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-May-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 EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021). At the time of the report, EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021) 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. she is scheduled to receive her 2nd dose
we gave him vaccine on Saturday (10/15) 6:00 PM and he started noisy breathing on Monday Night (10/17). He doesn't have Fever,  stuffy nose or runny nose.  He has problem only with breathing when he is sleeping and chest congestion. He is breathing from his mouth instead of nose and facing difficulty in breathing.  we gave over the counter medicine but problem continue so we visited medical group, on Thrusday(10/20) .
Immunization counseling provided. Discussed TdaP, MMRV, Hep. B, and IPV as well as influenza. Components discussed. Discussed risks and benefits. After immunization administration, printed updated immunization record from registry. At that time, discovered that child had received other immunizations that were not recorded in our records. Thus, received vaccines that were not due or necessary (TdaP, MMRV, Hep. B, and IPV). Informed father and apologized; discussed that he had received vaccines since the time we saw him last and dad was unaware of that. Also, the Hep. B received in June 2016 was not recorded in the registry printout from December 2020 that we used to enter vaccines into our records. Vaccines ordered at time of visit were based on information in records at the time. No adverse outcomes expected from getting extra protection through vaccines administered other than usual temporary risks of vaccines such as soreness.
serious neurological symptoms/the worst symptoms from the Omicron booster; This is a spontaneous report received from a contactable consumer (patient). A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2, After the second shot, patient had some significant side effects), for Covid-19 immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (Dose 3 (1st boosters), Insignificant ones for two boosters), for COVID-19 immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (Dose 4 (2nd boosters), Insignificant ones for two boosters), for Covid-19 immunization, reaction(s): "serious neurological symptoms". After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told doctor shortly after and to his/her surprise, she (the doctor) said they were serious neurological symptoms and getting another would be dangerous. Patient's very concerned about COVID so he/she wondered if there are any guidelines. Outcome of the event was unknown.   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-PV202300005067 same patient and event, different dose;
Arm pain; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.            Patient had arm pain and injection site was swollen from 2 months, she went to doctor, he gave her treatment as a steroid. It was reported that date of first vaccination and batch number was unknown. No concomitant medication was reported.
5 or so patiens got a those of the Moderna vaccine from a vial that was punctured for more than 12 hours.; 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 EXPIRED PRODUCT ADMINISTERED (5 or so patiens got a those of the Moderna vaccine from a vial that was punctured for more than 12 hours.) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 or so patiens got a those of the Moderna vaccine from a vial that was punctured for more than 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 or so patiens got a those of the Moderna vaccine from a vial that was punctured for more than 12 hours.) had resolved.        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.   Concomitants were not provided.  The reporter calling to get some guidance on an incident where a vial that had been punctured for more than 12 hours was used to administer the Moderna vaccine to several patients. The vial was puncture and used a few days later. Patients affected are unknown but HCP states that 5 or so. HCP states they think only one vial was affected and that they are not aware of previous excursion affecting that vial.  Treatment was not given.   Reporter did not allow further contact
Fever started on 11/15 at around 8pm with no other symptoms and treated with Tylenol throughout the night and following day for about 30 hours when the fever broke for 20 hours and returned on 11/17.  On 11/17 here were complaints of stomachache throughout the day that became severe by 7pm and followed by fever at 9pm.  After speaking with our pediatricians on call nurse two times I was advised to go to the ER as it sounded that it could be appendicitis.  It was not appendicitis or any infection that the ER tested her for.  The fever continued and developed diarrhea on 11/18 and both are still ongoing.
The rash started just around his neck as little bumps and with in 45 minutes the rash went from just his neck to all around his chest, arms and back. From there it got worse and became almost like little donuts. He was itching and very irritable and started running a fever. We called the on call doctor and they said take Benadryl. The next morning we took him to the Doctors office where the Rash was even more red and spread even more around his body. They said take Zyrtec. We got home and by 3:00 we took him back to the Doctor because he was getting worse and starting to swell. They sent us home and said just watch him. By that night he was running a fever of 102 and the rash was making his body swollen, his feet were purple and swollen and his face was swollen. The rash at this point had taken over his legs, chest, arms and back along with his face and in his hair. We went to the ER around 9:30 and he got a steroid shot and we came home around 1 am. Went to the Doctor again today around 12pm and they gave us Ranitidine and Prednisolone. He is still a little swollen but the rash is slowly calming down.
This spontaneous report was received from a registered nurse, via company representative and refers to her sister's babysitter's daughter of unknown age. Information regarding concomitant medication, pertinent medical history and drug allergies/drug reactions was unknown by reporter. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscular for vaccination (dose, lot number and expiration date were not reported). On an unknown date, the patient developed muscular issues. The event was reported as a debilitating condition as the patient no longer participated in sport activities. The outcome of the event muscle disorder and the causal relationship between the event and therapy with GARDASIL 9 were not reported. Upon internal review the event muscle disorder was determined to be significant disability.
pt inadvertently given HIB/hepb @ 35 days old; pt exp resp airway disease w/SOB & was hosp;the reporting MD felt that pt sx were not r/t vax; 60 day follow-up received on 10/25/00 provided no additional data.
Initial report received from other company (Novartis) on 13 May 2013. This case was initially reported by a healthcare professional. Other company reference number: PUS2013US040764. A patient, whose gender, age, medical history and concomitant medications were not reported, had received a dose of IMOVAX rabies vaccination (batch number, route and site of vaccination were not reported) on 22 April 2013. On an unspecified date, post vaccination, the patient experienced stiffness in the neck. Complementary investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Document Held by Sender: None.
17 days after my vaccine, I started experiencing migraines typical of those I experience several times a year. I have experienced these headaches most of my life at a rate of several (maybe up to 5 times a year to guess). I ended up with severe neck pain for several days which then turned into the first migraine of the week. I ended up suffering through nine migraines within one week. I?ve never experienced a cluster of migraines to that severity and quantity. Nothing else in my diet, lifestyle, or medications changed with the exception of the Janssen vaccine. When a migraine starts, I lose vision function (aura) and experience severe pain, nausea, fatigue, and sensitivity with migraines and missed a lot of work due to having nine within a week, plus several weeks to feel back to ?normal.? With these migraines, I experienced vision loss, nausea, severe pain and fatigue.  I had several phone calls with my neurologist, and was started on prednisone to try to snap the headache streak. When that didn?t work, I went to urgent care and received injections of toradol for the headache pain and finergan for nausea.
Patient called me last week after receiving the vaccine and then again today, 04/23/2018, to report that her arm was extremely sore, and the area around the injection site (about the "size of an apple") was red and warm to the touch.
I was asleep and awoken by burning and itching of my torso! I had a rash starting on my left side of abdomen then spread to the right and over the next few days, spread, less densely though, to my thighs and inner arms and some on my back.
First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on app to CDC).  Day 4 pain in right  hip began.  By day 7 rash had appeared on right buttocks and hip and below waist on right side.  Day 12 formerly diagnosed with shingles.
Body and muscle aches, headache, chills. Took ibuprofen to help with pain
Patient had an undiagnosed/unknown UTI at the time of her second vaccine on 3/2/21. She was admitted to Hospital on 3/3/21 with organ failure; she passed away on 3/5/21.  Her cause of death is listed as Sepsis, and UTI.  The vaccine was not listed as a cause of death, but might have been a "tipping point" in her inability to recover with antibiotic treatment.
pt recvd vax 10NOV93 & the next day devel a rash (urticaria); pt is treating self w/Calamine lotion & DPH cream;
pt exp pain, swelling, warmth @ inj site, neuritis/neuralgia, edema @ inj site; duration of 1 day;
PATIENT RECEIVED VACCINE, AFTERWARD SHE DEVELOPED TINGLING IN HER ARM AND FINGERS, TINGLING IS ONGOING SINCE VACCINATION.
Tremors; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Tremors) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced TREMOR (Tremors). At the time of the report, TREMOR (Tremors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.