chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an initial report of a serious adverse event, received on 17/Oct/2014, by a 35-year-old female patient/consumer. The patient received FLUBLOK TRIVALENT Intramuscular on 17/Oct/2014 at an unknown location. The patient developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath (SOB), all of which resulted in an emergency room visit. The duration of the events was 0 days and all of the events were considered recovered. Medical/surgical history reported no known drug allergy (NKDA) and egg allergy. Any illnesses at the time of vaccination were not reported. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. Further information is unavailable at the time of this report. The Company's assessment of the causal relationship between these events and FLUBLOK is that there may be a possible relationship based on the reported information that the reactions of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath occurred immediately after post injection. Addendum: significant correction was performed on 28-DEC-2018 to correct product FLUBLOK TRIVALENT (528) from FLUBLOK QIV (529). Sender's Comments: This case concerns a 35 years old patient who developed an immediate reaction of rash, facial flushing, tightness of throat, difficulty swallowing and shortness of breath. Time to onset is compatible. Etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient was treated by a physician for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 04-MAY-2016, the patient sought further treatment for continuing and worsening symptoms of zoster infections. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Moderna 11/09/2021, started experiencing symptoms 11/11/2021 of rash developed the left arm at the injection site spreading throughout to the elbow. No noted Primary visit/recommendations. Pharmacist communications recommendation for Cortisone Cream for self-treatment.
DX: Pneumonia due to COVID-19 virus;  80y.o. female who presents to ED with d/t left leg pain that was worsening overnight. On arrival to the ER, she is found to be hypoxic. She is placed on 2 L nasal cannula, found to be covid positive and admitted to the hospital. On examination on the floors, patient was found to have deficits of left sided weakness. Stroke code was called which revealed no acute process. Patient was not given TPA and she was on home anticoagulation. Patient continue to be treated for her Covid with Lovenox and Remdesivir.Patient was stable for discharge to a nursing center, with oxygen.
I have Covid again; I have Covid again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumonia vaccine, administration date: 2022, for Immunization; Influenza vaccine, administration date: 2022, for Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I have Covid again". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient stated that patient was 65 years old and received the 2 vaccines plus the Pfizer buster, as well as pneumonia and influenza vaccines this year. Patient have COVID again and have just been prescribed Paxlovid. Patient was very concerned since none of the studies explain are related to any case like them and patient believe that doctors do not have enough information about the possible adverse results, beyond the sour taste in the mouth and others. The patient asked that to give some other information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was hospitalized with Covid 7/19/2022-7/23/2022  Dose #1 give Moderna 2/4/2021 Lot #016M20A
Case number PHEH2013US020639, is an initial spontaneous report received from a nurse on 30 Sep 2013. This report refers to an unspecified age and gender patient. The patient received only MEN C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported), without being reconstituted with Men A lyophilized conjugate vaccine component on an unspecified date. Reporter stated that, she believes administration error occurred around the end of August. No more information was available.
whole body was vibrating; Dehydrated; arm hurt real bad; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad). On 06-Apr-2021, TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad) 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.   No concomitant medication was provided  No treatment medication was provided
Symptoms started morning after 1st shot and increased in severity through out the day.  Vertigo, dizziness, light headed and fainting. Mobility was mildly impaired in the morning.  By midday mobility was severely impaired, not able to walk straight, head spins, mild nausea.
Pt developed fatigue and tender L posterior cervical node. Developed a few more small L post cervical nodes over next few days then came to see me 5/09/11. She still c/o fatigue and was concerned about role of HPV vaccine in causing her sxs because she had "read about it online" She stated she didnt want any further doses for now. PE revealed only some shotty L post cervical nodes. Otherwise unremarkable.
This spontaneous report was received from a office manager and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 09-MAR-2017, the patient was vaccinated with M-M-R II, a single dose, lot number M028131, expiration date 03-JUN-2018, by subcutaneous route, (anatomical location and dose number were not reported), for prophylaxis. On the same date, the patient was inadvertently administered a dose of PROQUAD .No adverse effects reported. No product quality complain was involved.  Additional information has been requested.
She is upset and confused.; She is upset and confused.; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) 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: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious), CONFUSIONAL STATE (non-serious), outcome "unknown" and all described as "She is upset and confused.". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue. First time caller, consumer went to get her first covax which was Pfizer. 6 days later the vaccination site. called her and said that she only received saline injection. They gave her 2 options, start over with J&J vaccine or get second covax as scheduled. She states she went to her HCP because her arm was sore and she had fatigue. So her HCP told her she must had gotten the Pfizer covax. Now she was confused as to what she should do. Told her if she did get Pfizer covax cannot interchange. She was upset and confused.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379471 Same reporter/ drug, different AE/ patient;US-PFIZER INC-2021379474 Same reporter/ drug, different AE/ patient
Emergency room/department or urgent care; This initial information has been received on request by the Company from the agency on 18-AUG-2020, concerning an 18-year-old female patient. Information about medical history and concurrent conditions was not provided. Concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO).     On 16-AUG-2019 at 10:25, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029512, expiration date not reported, upon internal validation established as 08-JUL-2021, intramuscular in the right arm; strength and dose were not reported) for prophylaxis.    On 16-AUG-2019 at 10:30, the patient went to emergency room/department or urgent care (ill-defined disorder). The outcome of the event was recovered on the same day. The causality assessment was not reported.  Follow-up information has been received from the nurse practitioner on 28-SEP-2020. It was stated that the nurse practitioner could not identify this patient. She stated she will look at her patients for the vaccination date and see if she can identify this patient. No further information was available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029512; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
severe lower back pain started 2 days after recieving 2nd shot.  General muscle soreness/pain everywhere but primarily lower back pain.  Called Dr. He told me to give him advil.
Rash on upper arm around vaccine site (pink, discrete papules) a couple papules near clavicle. I suspect band aid adhesive contact dermatitis.
Patient complained of numbness/tingling in right arm/fingers about 5 min after the injection. She reports typically no numbness/tingling at rest and more so with movement on/off. Patient recommended to go to urgent care to today for further evaluation.
Immediately Following Vaccine:  1) Severe Hives within 10 minutes of vaccine - Took 50mg Oral- Liquid Diphenhydramine HCl Withing 1 week of Vaccine (documented at Doctor Appointment):  2)  Petechiae/Pupra Documented with photos 3) Unexplained bruising  - Documented with photos 4) Shingles - Documented with photos
This is an initial report of an Adverse Event, recieved on 23Oct2015, for FLUBLOK. A 28-year-old female subject, received FLUBLOK Intramuscular on 22Oct2015 at a Flu clinic at the dentist office. She developed a red patchy area about 4 inches below the injection site about 2x4 inches. The area was painful, with no itching, and slightly swollen. The inejction site was not swollen. It was painful the previous day and was very slightly discolored. The inejction site bled some after the inejction. At the time of the report, the outcome for the events was not reported. Concomitant medications were not reported.
flicking the syringe really hard multiple times to get rid of the bubbles was almost the same as shaking it; It actually gets stuck in the patient's arm; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. When drawing up COVID-19 vaccines using the Vanish Point syringes, small bubbles are trapped in the syringes and were hard to get rid of. They would have to be flicked multiple times. Our concern was, if the vaccine was not supposed to be shaken, flicking the syringe really hard multiple times to get rid of the bubbles was almost the same as shaking it, which may then compromise the vaccine was being administered. While administering the vaccine to a patient (needle was already in the patient's arm), the syringe started to leak out the vaccine causing the patient to be revaccinated due to uncertainty of dose administered. When retracting the needle from the patient (by pushing it further as part of its safety feature), it doesn't easily retract like it is supposed to. It actually gets stuck in the patient's arm. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sore; Swollen; Achy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On 12th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and pain. On an unknown date, the outcome of the injection site pain, injection site swelling and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, within 12 hours after vaccination with dose of shingrix, the patient experienced soreness and swelling in arm at the injection site and also felt itchy. The reporter stated that, the injection site was more swollen on the date of reporting than it was before the day of reporting. The reporter unable to obtain additional information. The reporter consented to follow up.
6JAN92 mom noticed petechiae on pt lower legs; no fever no other sx; 7JAN92 seen by MD platelet ct 22; 8JAN92 seen by MD again PLT ct 69; 13JAN92 PLT ct 632 to see MD in 2 wks 28JAN92; mom stated MD felt blood dyscrasia maybe related to vax
swelling at the inection sight; redness at the inection sight; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight). At the time of the report, VACCINATION SITE SWELLING (swelling at the inection sight) and VACCINATION SITE ERYTHEMA (redness at the inection sight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
On 11/21 the husband noticed that patient was having confusion and forgetting little things.  The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic.  The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk.  Once at the hospital the patient was given steroids, antibiotics, and antifungals.  The patient improved for two days and then got progressively worse each day after that.  The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28.  Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine.  8/26/08 Death certificate states COD as acute disseminated encephalomyelitis.    2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day   Admitted 11/21-11/28/2007 when she expired.  Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact.  Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds.  Received IVIG x 2.  By hospital day #4, conditioned worsened & was unresponsive w/left side weakness.  C/S neg & antibiotics/antivirals were d/c.  Continued to deteriorate & on vent.  Family decision to withdraw tx as condition contined to worsen & pt expired.   5/2/08 Reviewed pcp medical records which included vax record that confirms as reported.  Office note of 11/16/07 was for flu shot only, no pcp note.  10/24 vs for URI s/s x approx 1 week.  Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite.  Apouse had been ill w/viral syndrome.  CXR that day revealed patchy RUL infiltrate; CBC WNL.  10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder.  She had less cough & improved appetite but was still tired.  CXR that day revealed near resolution of pneumonia.  Records also included some hospital medical records. Neurosurgery & neurology consults done.  Patient w/fever on admission.
The first week I experienced pins and needles (peripheral neuropathy) , headache, fatigue, light headed, dizziness and severe brain fog.  Since that time ( 6 weeks later now ) I have developed chronic dizziness, especially when driving, head pressure, fullness in ears, brain noise, light headed, low stamina, dry eyes/ sometimes blurry vision.  On occasion I get nausea. I have had a couple of episodes of waking up with extreme pain in breast and down my arm.  I am extremely concerned that after 6 weeks these symptoms are not improving. I am also extremely frustrated and angry that the medical community refuses to address long term adverse reactions to these Covid shots.  It is a travesty to humankind to inject these shots that have caused so many short term and especially on going vaccine reaction symptoms. We are not being heard by the medical community which refuse to acknowledge the dangers of these vaccines for many people.  I am angry!  I have already been harmed by Cipro and now this vaccine as I was trying to do ?my part? in combating Covid!!
3 weeks of arm soreness and limited mobility, on examination, +induration and pain with movement of left arm
Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Body aches; weak; tired; arm soreness; swollen lymph nodes; Painful lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2022 at 16:45 as dose 1, single (Lot number: FR2587) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 19Dec2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 19Dec2022, outcome "unknown" and all described as "Both flu and covid vaccine in left arm/ administration date = 19Dec2022"; LYMPH NODE PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Painful lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 19Dec2022, outcome "recovering", described as "arm soreness"; LYMPHADENOPATHY (non-serious) with onset 19Dec2022, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 19Dec2022, outcome "recovering", described as "tired"; ASTHENIA (non-serious) with onset 19Dec2022, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain, asthenia, fatigue, pain in extremity, lymphadenopathy, lymph node pain.  Additional information: it was reported that no other vaccine in four weeks. Took 1000 mg. Tylenol 16 hours after injection, switched to Alleve 24 hours after injections. Tylenol 1,000 mg 38 hours after injections. It was reported that no treatment received for AE (not updated in tab). No covid prior vaccination and no covid tested post vaccination.
pt recvd vax; dx:throat infect; prescribed amoxicillin & given dimetap;no fever;mom states he was jerking w/ eyes rolled back;to er;adm x 3 days;tx for otitis med,no hx of previous sz;1st sz occured p/ amoxicillin adm;info provided via TC
COVID-19 symptoms started the morning of 07/07/22; tested positive on 07/09/22. The first symptoms were head congestion for 2 days and then the congestion got worse and I vomited, had fever of around 102 on Saturday and Sunday, and body aches. On Monday, I had a tele visit with doctor and she prescribed 5 days of a steroid pack, MUCINEX, FLONASE, and TYLENOL. I took all of those and I still have a little head congestion but most symptoms resolved within 24 hours of taking steroid. I was exposed 14 days prior by my husband.