chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a Vaxelis combination vaccine. Patient was also due for a pneumococcal vaccine; did not receive the pneumococcal vaccine.  HIB vaccine was given instead.   Patient referred to his  PCP to receive a pneumococcal vaccine at his next appointment. Our doctor will be notified.
patient was very anxious and nervous prior to the vaccine, and felt fine at the time of the shot, but became slightly nauseated and felt "nerves" and "like I was a nervous wreck"  - she felt overheated and was speaking calmly, in full sentences.  her HR and BP were normal at 76 bpm and 129/70.  her lungs were clear, heart was regular (known heart murmur), no skin changes, not sweating.   she rested and upon further evaluation was feeling fine.
Parient/daughter received covid shot on  8/4/21 at pharmacy.  On 08/7, patient was found face down having a seizure. She stopped breathing  and had no pulse and cpr was started and EMS called. Paramedics arrived and took over and were are to start her heart. She was ambulance to Er , transfered to Icu. She wasn't cognitive until the next day with no recollection of what happened and impaired short term memory. The hospital found that her potassium was low and it took a few days to normalize with supplementation. Many scans were preformed including brain and heart mri. Pt is under constant monitoring at hospital. They plan on sending her to another hospital for more test and possible surgery to place defibrillators.
Pain at the injection site; Mild fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022107252   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced pain at the injection site and a mild fever. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2022107252:Same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el9264), on 23Feb2021 as dose 2, single (Lot number: en6202), on 25Sep2021 as dose 3 (booster), single (Lot number: ff2589) and on 12Apr2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (unspecified if ongoing); "CKD" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Aug2022) Negative; (13Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with Paxlovid from 04Aug2022 to 08Aug2022. Received 2 negative covid tests 48 hours apart (11Aug2022 and 13Aug2022) after Paxlovid treatment.
Limbs feel cold; Limbs were hurting; Feeling a little Chilly; Minor headache; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (Limbs feel cold), PAIN IN EXTREMITY (Limbs were hurting), CHILLS (Feeling a little Chilly) and HEADACHE (Minor headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Limbs feel cold), PAIN IN EXTREMITY (Limbs were hurting), CHILLS (Feeling a little Chilly) and HEADACHE (Minor headache). At the time of the report, PERIPHERAL COLDNESS (Limbs feel cold), PAIN IN EXTREMITY (Limbs were hurting), CHILLS (Feeling a little Chilly) and HEADACHE (Minor headache) outcome was unknown.            No Concomitant medication were provided by the reporter. No treatment medication was provided by the reporter. Action taken with mRNA-123 is not applicable.
unclear if reaction was due to flu vaccine or Dupixent for atopic dermatitis pt developed Guillain-Barre syndrome resulting in quadriplegia, requiring trach/PEG
This spontaneous report was received from a consumer (the patient's mother) and refers to a 16 year old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies were reported. On 30-NOV-2015, the patient was vaccinated with her third dose of unidentified Merck HPV vaccine (the reporter could not confirm whether the vaccine was GARDASIL or GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not provided). Concomitant therapies included ADDERALL 20 mg. On 30-NOV-2015 (after receiving unidentified Merck HPV vaccine), the patient experienced headache, nausea and feeling faint. The outcome of the events was unknown. The relatedness between the events and the suspect vaccine was not reported. Additional information is not expected because the reporter declined to participate in answering questions within this adverse event report.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PAtient noticed an uncomfortable rash/swollen area two days after administration and wished to have it registered.
100  Fever; pain & muscle ache at injection site; daily  pressure headache at forehead; fatigue; daily migraine; dizzy; nauseous; eyes burning (mast cell attack?); partial loss of smell and taste.
Stated that One hour after receiving  the injection  she started having pain in right shoulder and up into neck that got progressively worse through the day.  The following morning she stated the pain was much worse (8-9 on 0-10 scale) and now has swelling and tingling in her right hand and fingers.
between 5 and 6 in the evening i started feeling a sharp throbbing pain in my right quad and then gradually my entire leg got tingly/numb feeling. in addition my symptoms of fever, headache, and body aches set in at this time too
This 22-year-old female took the first capsule of Vivotif (Batch no.: unknown) on 08.Nov.2006 and the last one on 15.Nov.2006. Four days after intake of the last capsule, on 19.Nov2006, she was in the sun and and developed a red itchy rash on head, hand and chest. A similar episode occurred on 25.Nov.2006. Benadryl gave her relief.
Received Tdap vaccine on 12/10/07 in right deltoid has had burning, painful sensation since receiving vaccine to right shoulder.
Started 10 minutes after vaccine lips were swollen and also had a hard time swallowing.
Shingles; This is a spontaneous report from a contactable consumer (Husband).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot no and expiry date were not reported), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient developed shingles two (2) weeks after receiving her second dose of the COVID-19 vaccine. Please send him a summary of how many other patients had developed shingles after taking the vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives on knee and stomach, severe itching on knee.  Put topical hydrocortisone on hives.  Doctor advised us to administer 1/2 tsp Benadryl, which we did.  Hives and itching stopped.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/18/21 (lot NA) Pfizer Dose 2 3/11/21 (lot NA) COVID Positive 12/7/21  12/7/21: patient is a 48 year old male who presented to ED with a chief complaint of shortness of breath.  He is vaccinated against COVID-19 but he has had exposure to his sister who tested positive yesterday.  He reports fever, chills body aches and productive cough on and off over the past 3 weeks.  He denies any nausea, vomiting or diarrhea.  He denies chest pain.  He has a past medical history significant for asthma, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, peripheral neuropathy, attention deficit disorder, coronary artery disease   On arrival to ED patient was hypoxic on room air at 83% and febrile 100.0, patient was placed on 4 L oxygen with improvement oxygen saturation.  Laboratory findings were significant for hyponatremia 132.  Hyperglycemia 296. AKI on CKD BUN 50 and creatinine 2.96.  Hypocalcemia 8.5. Lactic acidosis 2.2.  Anemia HGB 11.5.  ESR 71. D-dimer 1.40.  C reactive 19.30.  Chest x-ray new bilateral infiltrates suspicious for viral pneumonitis or atypical pneumonia  12/17/21: This patient with a history of COPD, diabetes, coronary disease, peripheral vascular disease and ADHD had been ill for 3 weeks and finally admitted to the hospital with COVID-19 pneumonia.  He has had a prolonged course and did receive dexamethasone, Remdesivir and Actrema.  He still requires oxygen at rest and more with activity.  He has an amputation and is been ambulating with his prosthesis.  He will be able to go home today with his usual diabetic medications and home oxygen.  The D-dimer and CRP level remain high and been recommended that he go home on continued anticoagulation, with enoxaparin 80 mg b.i.d. for least 7 days.  He should follow up with Pulmonary on the duration of the DVT prophylaxis.
Pt called on 10-27-16 at 10:30 am: states received vaccine on 10-17 arm/shoulder at site swollen and sore on 10/18+19 than was fine but on 10/24 wrist and hand became swollen. She could not reach her MD. Pt says ice makes it fell better. Advised her to continue to ice prn and try to contact MD. Pt does not want to take APAP.
Pt fainted. Per mom - seizure-like movement for a few seconds. Then became alert and awake. I saw pt immediately after the fainting episode - no post-ictal. No follow-up required.
At 10:55 AM, within five minutes of the vaccine being administered (at 10:50 AM), I felt light headed.  Around 40-50minutes later (around 11:45-11:55AM) I felt light headed; my face felt hot; At 10:55 AM, within five minutes of the vaccine being administered (at 10:50 AM), my face felt flushed.  Around 40-50minutes later (around 11:45-11:55AM) I felt flushed.; At 10:55 AM, within five minutes of the vaccine being administered (at 10:50 AM),  I had a rapid heart beat. It lasted for about ten minutes (ended around 11:05 AM)and I left to go home. , and a rapid heart beat for 15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:45 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy (anything in the -cycline family). The patient previously took doxycycline and experienced allergy to the medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 20Apr2021 at 10:55, within five minutes of the vaccine being administered, the patient felt light headed, the face felt hot and flushed, and had a rapid heartbeat and it lasted for about ten minutes (ended around 11:05 AM). Around 40-50 minutes later, the patient again felt light headed, flushed and a rapid heart beat for 15 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headedness, hot and flushed face and rapid heart beat was resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 05-JUL-2007 was vaccinated with her first dose intramuscularly with 0.5 ml of Gardasil. There were no concomitant medications. On 05-JUL-2007, 3-4 hours after vaccination, the patient developed a severe headache. The patient was treated with ibuprofen (MOTRIN). The headache lasted six days. On approximately 11-JUL-2007 the patient recovered. There were no laboratory or diagnostic studies performed. Additional information has been requested.
Frequent irregular heartbeat (PVCs) starting almost 3 weeks after first shot. Went to ER on 4/2 after frequency and discomfort of PVCs increased (3 days after second shot.) Had ECG, bloodwork, and chest X-Ray at ER, returned home and followed up with my PCP.  Went on prescription beta blocker to control PVCs, had a TTE and Holter monitoring, and all symptoms resolved after 4 weeks of being on beta blocker.  Still planning to follow up with cardiologist, have not been able to get an appointment yet. My PCP and I find it very unlikely that my issues were related to vaccination, the timing seems coincidental to me.
After receiving my 2nd dose of the Pfizer COVID vaccine I have not been able to get any REM sleep - all sleep is shallow and light with multitude of odd dreams waking several times per night and never feeling rested. Prior to this I have always been a deep sleeper and only needing 6 hrs to feel rejuvenated and rested.
Five mins. after injection - patient was tachycardic; then another 5 mins. started to have flushed face, then on the chest and back and extremities - given BENADRYL 25 mg I.M. Brought to ER - given steroid.
Diarrhea; Food gets stuck in his throat it's hard to swallow; It is like his mouth doesn't work right; His lips won't close and water spills out; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730), via an unspecified route of administration in left arm on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history included occasional headache. The patient's concomitant medications were not reported. The patient previously took aspirin. Historical vaccine of the patient included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration (at 68-year-old) on 24Feb2021 for COVID-19 immunization. On an unknown date in Mar2021 patient had diarrhea since his second shot and all the tests his doctor performed had come back negative. He mentioned that diarrhea was a side effect of this vaccine and he was wondering if you have a cure for this or was this now his life. There was a couple other issues that had come up around that same time (Mar2021) and he was unsure if they were related and he had not talked to his doctor about them yet because he had been more concerned with the diarrhea but sometimes when he was eating, food seemed to get stuck in his throat and then it was hard to swallow so he tried to drink and then it was like his mouth does not work right and his lips would not close and water spills out. On 28May2021 the patient reported that it was actually a very bad day. He mentioned that diarrhea was persistent for 4 weeks and then it almost went away for a week or two and now was back and bad as ever. The outcome of events was not recovered.
Erythema To RT Deltoid post Pneumovax very itchy spreading. Malaise no fever. Placed on Keflex and Benadryl.
Patient reports itching in the throat and light headed. Benadryl 25 mg administered. patient become better after after 20 minutes. Vitals 98%. patient allergic to sulfa.
arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 PAIN IN EXTREMITY (arm was really sore). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Pain in left jaw, pins and needles in left side of face, headaches in left side of head
the pneumovax was ordered. All appropriate screening questions were reviewed with the pt. the injection was given at 12:10 pm. At 12:20 pm the patient c/o feeling dizzy, faint. Pt was lowered to the floor. BP 110/70 P-60. Pt c/o nausea. Vomited several sm amts. Dr was in attendance and pt was transported to the Hospital Emergency room since she then starting to c/o of tightness in chest. SPO2=96%. was seen at the Hospital ER -given SoluMedrol 125 mg IV, Benadryl 50 mg IV and Zofran 4 mg IV. pt also received DuoNeb treatment.
Had altered sensorium several minutes after having received ZOSTAVAX. He was tremulous and confused, but with stable Physical exam and vitals, but for markedly elevated BP in the 190's, normal glucose. He was packed for transport by EMS, where I accompanied him to the ER. Considerations would be a reaction to vaccination, hypertensive emergency w/altered sensorium. Per hospitalist note in ED. Confusion and acute loss of consciousness, tremors.
Systemic Reaction: Erythema, fever, Tenderness, and edema R Deltoid
Patient and his younger brother were in office for Flu and Covid vaccines. I was assisting a newer M.A. in drawing up/administering.  Discussed vaccinating different ages and encouraged drawing separate trays and labeling each with name/age as with Covid vaccine. We prepared two separate trays each labeled for the boys with their separate ages, 5-11 (Patient) and brother (6m-<5yrs.) Brother was going to go first, then did not want to.  Brother was crying. Patient said he would go first.  I had Brother's tray and administered the Flu and YOUNG CHILD Covid to Patient who should have gotten the 5-11 dose. I realized my error immediately afterwards as having grabbed the wrong tray.  We took a time out, I explained my error to co-worker. I had staff re-draw the 6m-<5yr dose, verified, and we went back in. I apologized to mom and explained what had happened, that Patient got the dose intended for a younger child. Told mom that I will find out from Health Dept. what to do. Mom expressed understanding and will wait to hear what is recommended. Staff administered the imms to Brother with the correct dosing. I apologized to mom again.
I have had an incidental finding of a 16 mm ground glass nodule in the right lung upper lobe. 2 days after having the vaccines (both), I experienced incredible chest pain that resolved in about 30 minutes.  I have not had COVID pneumonia.
Swelling and tenderness of left arm. Heat, redness 23 cm decrease x 20cm x 8cm vesiculation. Inpt: Ancef;Bactrim warm compress. 2/21/06 Received medical records which revealed patient experienced arm pain, edema, erythema, heat, vesicular eruption, drainage & skin peeling at injection site.  Hx of asthma & anemia./ss
Information has been received from a physician concerning an approximately eleven or twelve year old female patient who was vaccinated with the third dose of GARDASIL.  Subsequently, after receiving the third dose of GARDASIL, the patient "went into a" seizure.  The seizure lasted a couple of seconds and then the patient was "ok."  The patient sought unspecified medical attention.  It was reported that the patient was "ok" after receiving the first and second doses of GARDASIL.  No product quality complaint was involved.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
p/vax pt rt leg edematous; rt thigh measures 12''; lt thigh measures 10 3/4 at inj site
AT 9:20 PATIENT STATE FACE TINGLING NO APPARENT DISTRESS.  NO TROUBLE SWALLOWING. AT 9:25 PATIENT NOW STATES THAT TONGUE FAT.  AGREES TO GO TO URGENT CARE ASAP.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 3/17/21 and 4/14/21. Presented to ED w/worsening SOB and vomiting. Dx'd w/covid 2 weeks prior. Admitted to ICU for acute hypoxemic resp failure requiring intubation, COVID PNA, AKI, and severe septic shock. Had an NSTEMI; evaluated and tx'd by cardiology. Condition deteriorated w/worsening lactic acidosis, renal failure requiring CRRT, liver failure, and signs of worsening neurologic function. Per surgery not stable for acute abdomen exploration. Code blue called for asystole, no ROSC. Exp'd on 9/15/22. Pt tx'd with cefepime, metronidazol, bactrim, azithromycin, decadron, and ceftriaxone.
left arm pain, pain and weakness  -continue pain med's as needed, ice, monitor symptoms and f/u if not better
Unable to follow up with customer - phone disc. Per conversation of operation manager with the patient. Following the shot, she began to have soreness in her arm, soreness did not go away and she visited her primary care physician to receive a cortisone shot. The shot was not effective. She returned the next week for another cortisone shot. As of 10/19 she is staring to feel better.
Daily headaches; This is a spontaneous report from a non-contactable consumer.   A 57-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 05Jan2021 for Covid-19 immunisation.  Medical history included long QT syndrome, depression, anxiety. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA), nadolol (NADOLOL), doxycycline (ORACEA). The patient previously took bacitracin and experienced allergy. Patient vaccine history included the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) at single dose at left arm on 15Dec2020 for Covid-19 immunisation, administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced daily headaches on 06Jan2021. No treatment received. Covid was not tested post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No furhter information is expected.
Rash on all areas of body, small lesions, mottled skin appearance. Treated with antibiotic therapy and steroid treatment (Prednisone) additional Puva treatment (8 wks)