chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mouth, lips and throat felt funny like Novocain was wearing off in my mouth/ my face felt odd too; body felt very heavy; very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 11Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, autoimmune disorder, bee sting hypersensitivity and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), vitamin b complex (VITAMIN B) and levothyroxine sodium (SYNTHROID); all for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received prochlorperazine edisylate (COMPAZINE) and erythromycin (MANUFACTURER UNKNOWN), both on an unknown date and experienced allergy. On 11Mar2021 at 10:35 (onset time also reported as 10:30), about 20 minutes after the vaccination, the patient was walking outside the office and the patient felt her mouth, lips and throat felt funny like Novocain was wearing off in the mouth. It was reported that the patient's pulse and breathing were okay but the patient felt her face odd and felt her body very heavy. The patient opined that it was clearly a reaction and not severe but the patient's fear was, would the next vaccine be more severe and whether it was needed to worry about throat closing. Even the throat closing did not happen but the patient was worried. This all subsided in a few hours. The patient kept fluids going and ate lunch. The patient was very fatigued and lied down for about an hour. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included treatment as fluids and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth, lips and throat felt funny like Novocain was wearing off in my mouth/ my face felt odd too, body felt very heavy and very fatigued were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Dizziness - pharmacy technician did not give me the option to wait - it was not offered or recommended.  Immediately after the vaccination was given, I was free to go.  I had a few things to pick up in the store and as I was headed up the aisle to the checkout, I immediately became dizzy and had to hold on to the shelf to keep myself upright.  As I approached the counter, I noticed the pharmacy staff was heading out on break.  I stopped one of the reps and explained that I didn't feel well and asked if I should go and sit down until the dizziness subsided.  She replied yes and explained that they were on lunch but the pharmacist may come out.  As I head back to the rear of the store, I continued to feel dizzy.  The pharmacist was coming from the back (an office outside of the pharmacy) to accept a delivery and I explained that I was dizzy and was going to sit down.  He shook his head yes, but never came back to check on me.  I waited approximately 20 -25 minutes then left the store.  *After talking with relatives and friends, all of them were required to wait at least 15 minutes before becoming mobile.  Perhaps this option wasn't given to me since it was close to the time when the pharmacy closes for lunch.  Later that day, my left leg began to hurt near my calf and it was extremely difficult for me to walk.  I googled the side-effects and read that muscle cramps were possible, so I did not seek further medical attention.  The pain was intense but had resolved by Saturday morning.
Case number PHEH2014US006399 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at a dose of 0.5 ml intramuscularly on 26 Mar 2014. The MENVEO reached 32 to 34 F for up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe vaccine was frozen. No adverse event was reported following this administration error.
Reaction on the deltoid posterior area; Swelling; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Communications (reference number: SEQW20-04044) with additional document received on the same day (being processed together) form other non-health professional via Communications (reference number: SEQW20-04036) and concerned a patient of unknown age and gender.   The patient had no relevant medical history and was not taking any concomitant medications.   On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was 283847 and expiry date: 30-Jun-2021.   On the same date, the patient experienced redness, swelling, itching and a reaction on the deltoid posterior area.   On an unknown date in Oct-2020, the patient was admitted to the hospital due to the events. The patient was treated with clindamycin intramuscularly, dexamethasone intramuscularly and Benadryl (diphenhydramine hydrochloride).   At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the events and was still hospitalized.   The reporter assessed the case as serious due to hospitalization.  This case is linked to case 202005386 (same reporter).  Company comment: The patient developed erythema, swelling, adverse reaction (reported as ''reaction on the deltoid posterior area'') and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).   Sender's Comments:  The patient developed erythema, swelling, adverse reaction (reported as ''reaction on the deltoid posterior area'') and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Tdap was given and then HPV and within minutes patient got dizzy and passed out for approx 30 seconds. During this time she did have muscle stiffness and some twitching. Upon waking she was hit and nauseous with a heart rate of around 105
bumpy at injection site; Itchy at injection site; Looks like a rash; Red at injection site; A spontaneous report was received from a Consumer concerning a 69 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at injection site, itchy at injection site, bumpy at injection site and looks like a rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 0321L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced redness at injection site, itchy at injection site, bumpy at injection site and looks like a rash.  No treatment taken.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Narrative:  PATIENT WAS IMMUNIZED IN TIMELY MANNER WITH PFIZER MRNA VACCINE ON 2/28 AND 3/21 RESPECTIVELY.  PATIENT PRESENTED TO ED ON 11/8 WITH COMPLAINTS OF SOB AND PRODUCTIVE COUGH AND TESTED POSITIVE.  PATIENT WAS GIVEN DEXAMETHASONE AND REMDESIVIR, STEROID INHALER ADDED, AND UP TO 2L NC 02 SUPPORT PROVIDED FOR COPD EXCERBATION/COVID PNEUMONIA. PATIENT IMPROVED AND WAS DISCHARGED HOME.
Swelling in ears, redness on ears and scalp , itching and slight rash over body
Administered expired vaccine. Per Moderna this vaccine is likely effective, but not definitively. Patient will be advised to re-do this dose.
Had a rash on that arm, less than 6 inch area and chills that night.  Things were normal the next day,
VASOVAGAL SYNCOPE IMMEDIATELY AFTER GETTING ALL THREE VACCINES, CAME TO IN MOMENTS AND RECORDED CONFUSION AND PALENESS TO SKIN ( MAINLY FACE), MONITORED VITALS AND RELEASED AFTER 30MINS.
Swollen lymph node in the arm that injection was given.  Experiencing extreme fatigue about 6 weeks after vaccination.
minor swelling of eyes 5PM 24MAR92; fever, swelling @ area vax given w/some pain 25MAR92; MD ordered DPH & APAP w/codeine;
SHINGLES; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 01-JUL-2022. The pt's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around July 2017, the pt was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for the prevention of shingles. Shortly after the vaccine, the pt suffered shingles. As a result of these symptoms, the pt had experienced physical limitations not present prior vaccinations. The pt also experience mental and emotional distress due to resulting physical limitations and serious condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster to be disabling event.
toothache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) 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: TOOTHACHE (non-serious) with onset 12Mar2021, outcome "unknown", described as "toothache".  Additional information: The patient got her 1st dose today and she experienced a toothache. The patient was asking if she could take antibiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness and diaphoresis that occurred approximately 5 minutes after receiving vaccine. Patient placed in supine position and symptoms resolved in approximately 5 minutes.
Patient called clinic 4/13 to report having been seen by PCP and in ER twice since vaccination. She reported onset of headache and fatigue day of vaccine. She reported later feeling short of breath and having a  decreased tolerance of activity.  She stated she had an elevated heartrate and "neurological symptoms", but did not specify. She reports still feeling off at this time 4/13 and having appointments scheduled with a Vascular surgeon and neurologist in the near future. I am doing the reporting as the vaccine was given by Public Health staff, but this is the first notification we have received of the her potential adverse reaction.
After 10 minutes of giving vaccine MMR patient had a wheal were vaccine was given. Symptoms was only pain, looked red. 12:05pm.
Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
12 hours after getting vaccinated, I woke up with vicious chills.  I took my temp and it was 102.5 F. I became nauseated and then fainted, smacking the back of my head on the bathroom floor. I took naproxen (220mg) for the fever and returned to bed. At around 8am I got up and my fever was 101F and stayed at that temp for 24 hours. I fainted again and blacked out for about 30 seconds.  I stayed in bed all day.  My fever broke by Sunday morning and I started to feel better by midday.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERID, start date: 10Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after the shot, I started having irregular heart beat and it lasted about 2 or 3  weeks, and that went away.  I felt tired on  2nd of feb in the evening, the next day i could barely move, I had  itchy throat and nose . I had a COVID -19 test, on feb. 3rd,  the results were negative After the 4th I felt better. After a couple of weeks I felt very fatigue, my muscles felt weak and they have been twitching since then, they are still twitching they are just less fatigue.It lasted about a month to two and a half months. It has been gradually getting better, but it started since February after the vaccine.
She got her first vaccine, when she got it it hurt so bad is screamed and within an hour it swelled up.  Then by 1:00 she started throwing up.  She has lost range of motion, cannot pick up anything and the whole side of her body hurts, is weak, and has lost all muscle movement in that side of her body.  She cannot hold a pencil, cannot squeeze a washrag, cannot pick up anything heavy.  She hurts in her hand and the whole arm.  She went to her doctor and they told her that they cannot do anything about it, CDC did not tell them what to do and that there is nothing that they can do.  She has been to the HD 5 times.  She also has had blood clots in her legs that evening, throwing up blood that evening and nose bleeds.  She was told to put her legs up when she went to the ER and they gave her cold packs.  She was put on the Gabapentin by Dr. her specialist, neurologist.  She does still have the blood clots and still throwing up blood that makes her weak all over her body.    She subsequently had her 2nd vaccine on 5/7/21, Pfizer EW0179, in her right arm as well.  Her arm swelled up again, and nose bleeds that night as well, the same thing happened each time she got a vaccine.   She then got her 3rd vaccine on 1/8/22, Pfizer FD5217, same reaction as previous vaccines.  Arm swelled up, nose bleeds.  She has lost muscle strength in her legs, arms and weak all over.  She then had her 4th vaccine and again she had the same symptoms.    She went to the ER and when she feels like a truck hit her she goes there, and they give her ice packs, pain shots, pill for pain, give their MRI, EKG for her chest pains, then they send her home.    She also has confusion, fog, has lost sight in her vision.
We gave an expired DTaP. Expiration date was 5/11/23, and we gave the vaccine on 5/15/23, accidentally. No adverse reaction.
Pt recvd 3 doses of Engerix-B vax & 4DEC91 found to be non-seroconverter;
This spontaneous report was received from a currently 73 year old female patient regarding herself. No concurrent conditions, medical history or allergy/drug reactions were reported. In December 2014, the patient was vaccinated with ZOSTAVAX vial (lot # J012660, expiry date: 10-JAN-2015) (strength, dose and route unspecified). Concomitant therapy included levothyroxine sodium. Within two weeks of receiving the ZOSTAVAX, the patient presented with "psoriasis-like" lesions. The patient visited the doctor in the last few weeks and lab work was done on a sample identified these lesions as psoriasis. The patient was treated with an unspecified cream. The patient reported that she never had psoriasis prior to the ZOSTAVAX injection. She wanted a lot check done to see if other recipients of this particular ZOSTAVAX batch experienced psoriasis since having the injection. These lesions were still present as of the date of this report (not recovered). There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information is not expected, no contact details were provided.
Patient received 3rd dose of vaccine due to documentation error. 1st dose given on 1/13/21, 2nd dose on 2/8/2021, and 3rd dose on 2/11/2021. No adverse effect noted at this time.
Raised/circumscribed rash over left deltoid area at ER. Several inches in diameter.
I had a rash on my left arm and forearm. It was red raised painful rash. This is still ongoing. I had chills, headache, and congestive. I had fatigue. These started later on Tuesday. I went to the urgent care. They did not do any test. They diagnosed me with shingles.
pt recv vax 20AUG96 1130AM & <2hr later pt had diffuse hives;pt instructed to to to hosp;pt sleepy;pt exp gen flushing & hives;rash remains prominent over legs, dec face/arms by 215PM;also dry cough;reddened ears, abd, & extremities;
Patient with COVID vaccines who admitted with positive COVID PCR and complications from PNA who subsequently died.  Provider d/c note:  "78 yr old male with PMHx of HTN, HLD, hypothyroidism, DM2, OSA and dementia who initially presented for altered mental status and generalized weakness.  He was intubated for failure to protect his airway in the ED.  He met SIRS criteria with elevated wbc and temp.  He had a CT chest which showed consolidation in right lower lobe and patchy groundglass opacities in right upper lobe and left lower lobe.  He was started on ceftriaxone and azithromycin due to CAP.  He was started on Levophed due to septic shock.  Wife decided to change code status to DNR with no escalation of care.  He had elevated AST and  alk phos and so he got an abdominal ultrasound which showed acute cholecystitis.  General Surgery was consulted and due to his critical condition, he had IR place a cholecystostomy drain.  He had blood cultures that were positive for E coli, Bacteriodes fragilis and vancomycin susceptible Enterococcus faecalis so he was started on Zosyn and vancomycin.  He was eventually weaned off of sedation but his altered mental status did not change and he failed SBT.  He continued to spike fevers throughout his stay.    He was weaned off of pressors but needed to be placed back on them due to recurrent hypotension.  He developed an AKI which resolved after fluids.  After a long discussion with his wife, she elected to make him comfortable and agreed to terminally extubate him due to poor prognosis.  He was pronounced dead on 11/21/22 at 0113.  "
Left arm swollen and red.  Treated with Benadryl and ice packs.  Went to ER due to pian on 4/24/07.  ER MD diagnosed as infection and allergic reaction.  ER treated with Motrin and Cephalexin 500 mg TID.
15:00 Temperature 103 F, crying, eyes sleepier. 15:10 Still crying, Tylenol had been given and is having tremors.
Swelling and itching at injection site. Seemed to subside but then reemerged a week after vaccination.
The patient presents with COVID-19. 76 year old male, who tested positive 1 day ago, presents to ED with COVID-19 symptoms. Pt states he is experiencing weakness, cough, sob, fever, and diarrhea. Pt denies abdominal pain, chest pain, and palpitations.  The onset was 1  days ago.  The course/duration of symptoms is constant.  Associated symptoms: weakness, cough, sob, fever, and diarrhea, denies chest pain and denies sore throat.  Risk factors consist of diabetes mellitus and COVID-19 infection.
Pt had 2 immunizations - Tdap administered in (R) arm, then MMR administered in her (L) arm. Pt fainted and vomited after second immunization. Husband brought pt back to consciousness while I called 911. Pt was OK after recovering and did not want further treatment from Emergency personnel.