chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't feel some of her toes; Toes she couldn't feel were totally white; Raynauds; Shingles; burning; itching and blisters on back; itching and blisters on back; This is a spontaneous report from a contactable other hcp.     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 07:30 (Batch/Lot Number: EL3248) as single  dose for covid-19 immunisation.  Medical history included ongoing allergies, ongoing anaphylactic reaction, raynaud's phenomenon from 2021. Patient informed she was MTHFRA1298 positive. it's kind of like a mutation, says when you're homozygous you usually don't have any issues with clotting or bleeding. The trouble was with heterozygous, says some family is heterozygous and have had bleeding and clotting. Her twin sister and brothers are all homozygous. Patient also informed her father has had autoimmune issues like ITP, so his platelets weren't forming, and if there was bleeding he had to be careful. She reported also her platelets have been fine and both hemoglobin and hematocrit were fine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d deficiency, start and stop date were not reported.  The patient experienced couldn't feel some of her toes (medically significant) on an unspecified date with outcome of unknown , toes she couldn't feel were totally white (medically significant) on an unspecified date with outcome of unknown , raynaud's phenomenon (medically significant) on an unspecified date with outcome of unknown , shingles (non-serious) on Feb2021 with outcome of recovered  on 2021, burning (non-serious) on Feb2021 with outcome of recovered on 2021 , itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021, itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021.; Sender's Comments: Based on the current available information, the events Numbness in toes and Skin discolouration, and Raynauds are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes 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.
5/4 afternoon/evening: soreness at injection site. 5/5: mild flu symptoms (headache, mild fever, chills, body aches) 5/6: improving. 5/7: mild fatigue.
Fever and chills. Ended up going to bed the next night very early. Feeling better now on the 2nd day
This spontaneous report as received from a registered nurse refers to a 28 year old male patient. The patient was supposed to received his first dose of PNEUMOVAX23 but on 10-OCT-2013, the patient was inadvertently vaccinated with a dose of GARDASIL (Lot number was reported as J008423, expiry date was 21-JN-2016), 0.5 milliliter (ml), intramuscular. The nurse stated that the patient had never received any previous doses of GARDASIL. Also PNEUMOVAX23 had not been administered at this time. No adverse effects were reported at this time. Additional information has been requested.
Rash/hives all over body, increased blood pressure, heart rate 150. Struggling to breathe.
Patient called on 9/20/19 and said that her arm was swollen, red, painful and inflammed where she had received the vaccines. When I asked if she was running a fever she said yes. I advised her to alternate between ibuprofen and tylenol and to call me the next day to update me on how she was feeling. I called her back on Saturday and she said she felt much better and that her fever had gone down but her arm was still swollen and red. I advised her if she was still concerned to contact her doctor. She mentioned that it could have also triggered a fibromylagia attack.
Mild reaction: hives; Mild reaction: Tachycardia; This is a spontaneous report from a contactable other HCP. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild reaction hives and tachycardia on an unspecified date with outcome of unknown. The reporter asked if patient can still continue with the second dose.  Information about lot/batch number has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 03-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Vaccine was drawn up by another nurse inadvertently without diluting first. Patient received .3mL of undiluted Pfizer vaccine. Patient's father was notified as soon as error was discovered. Patient to return to clinic on 7/30/21 to be evaluated.
This case was reported by a nurse via other manufacturer and described the occurrence of heart attack in a 57-year-old female patient who received Influenza vaccine. Previously administered products included Acetaminophen (daily 500 mg every six hours orally), albuterol (started on 1st December 2015, inhale 2 puffs into the lungs every 6 hours as needed) and NEURONTIN (started on 17th September 2015, 300 mg 3 capsules orally tid). Concurrent medical conditions included drug allergy (with various drugs). On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack was unknown. It was unknown if the reporter considered the heart attack to be related to influenza vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient also had other medications which included Primidone, LYRICA, Levothyroxine, Tramadol, Loratadine, carbidopa-levodopa, Gabapentin, Lisinopril, Benztropine mesylate, furosemide, NITROSTAT, Pramipexole dihydro, Meloxicam, VENTOLIN, polyethyl glycol powder, metoprolol tart, Aspirin, Acetaminophen, melatonin, IVP dye, Caesine, Azithromycin, codeine, cyclobenzaprine, NSAIDs, ZYRTEC, AEROBID, ENTEX lq, FLOVENT, latex, morphine, morphine and related, NIZORAL, PROVENTIL, ROXICET, saccharin, VICODIN, Aspirin, ATARAX, caffeine, contrast and other medication and muscle relaxant. The medication reported as current medication were COGENTIN, SINEMET, CLEOCIN, LASIX, NEURONTIN, SYNTHROID, LEVOTHROID, PRINIVIL, ZESTRIL, CLARITIN, Melatonin, MOBIC, LOPRESSOR, NITROSTAT, MIRALAX, MIRAPEX, LYRICA, MYSOLINE and ULTRAM. The patient received flu viral vaccine and experienced stopped heart per patient.
Pt recvd a series of 3 Engerix-B on 29OCT90, 6DEC90 & 22APR91; on 15JUL91 when Antibodies were tested it was determined that pt was not seroprotected; Pt recvd 4th dose on 25JUL91; was seroprotected p/4th dose; tested 3SEP91;
The vaccine was done at 12:42pm on 02-04-2022. After investigation we discovered that the injection  was accidently taken from a mixed pediatric pfizer covid vial(orange cap)  approximately 19 hours after the vial was mixed .   We have called Pfizer medical information area and from what we gather recent studies have shown that a mixed vial is stable for up to 24 hours at temperatures between 35 and 86 degrees F.     Thus far we are not aware of an adverse reaction.
Injection site hot to touch, swollen, itchy, and hurts to touch. Extreme Fatigue.
This patient experienced chills, fever, body aches, nausea, and a headache.    Symptoms subsided 24-48hrs after booster was given.
A few minutes (about 10) after she received her vaccine, she started with an itchy throat, then a cough, then she vomited and couldn't breath well. She was given some benadryl and some water and she began to feel better. She said her throat was only slightly itchy the next day.
Next day - Patient had onset of shortness of breath, CXR and CTA chest were negative.  EKG showed possible old MI, no acute findings.  Cardiology referral was made.  He wasn't seen.  He came in on 5/6/2021 and ended up being admitted with non STEMI and new CHF.
10Apr2021 Joint pain (toes, ankles, knees and hips) starting at 6pm - currently ongoing - took two 200mg Advil, no resolution.  Mild fever 100.4 at 10pm - took two 500mg Tylenol, fever subsided at 11pm 11Apr2021 Continued joint pain, took two 200mg Advil at 2pm, no resolution.  Took two 500mg Tylenol at 10pm, was able to sleep until pain woke me up at 6am. 12Apr2021 New painful, swollen, red, warm to touch bump at injection site, visible after shower at 8am - currently ongoing. Continuing joint pain, took two 500mg Tylenol at 9am, helped for a little bit, pain still ongoing (more like intermittent sharp pain now).  New hives appeared on my face at 10am, took 25mg of Benadryl, slept for four hrs, hives subsided.
could not lift injection site arm; large red welt on her neck on the same side where she got the vaccine; chills; njection site arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift injection site arm), URTICARIA (large red welt on her neck on the same side where she got the vaccine), CHILLS (chills) and VACCINATION SITE PAIN (njection site arm sore) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift injection site arm), URTICARIA (large red welt on her neck on the same side where she got the vaccine), CHILLS (chills) and VACCINATION SITE PAIN (njection site arm sore). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift injection site arm), URTICARIA (large red welt on her neck on the same side where she got the vaccine), CHILLS (chills) and VACCINATION SITE PAIN (njection site arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Morning of 5/7/2019 developed sudden fatigue and numbness and tingling of both arms, felt like she was going to pass out but laid down and did not have any episode of loss of consciousness. The episode was witnessed. Subsequently developed fatigue, body aches and chills, numbness and tingling is resolving at the time of the report.
Received COVID 19 Treatment; Received 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 12Apr2021 as dose 2, single (Lot number: EV-158) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 19Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 002F), in right arm and on 06Mar2022 at 12:00 as dose 4 (booster), single (Lot number: R19CP2R7), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Dysphagia" (unspecified if ongoing), notes: other medical history: Mild Dysphagia; "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Received COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Still not feeling well, aches, headache, cough and congestion worse and testing positive - finished doses 2 days ago. No fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient admitted to Hospital on 3/25/2021 for shortness of breath and chest pain; work-up revealed pulmonary embolism. Patient started on Lovenox while inpatient; patient was discharged on warfarin on 3/29/2021. Of note, pulmonary embolisms were bilateral and there was no evidence of right heart strain on echocardiogram performed while inpatient.
Severe headaches, severe abdominal pain, severe swelling and pain in glands under chin, nausea/vomiting, fever chills, hallucinations, confusion, decrease in mental acuity,abortion pain in joints and muscles.
tinnitus worsened; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were not reported. Patient stated that She had tinnitus, and after the shot her tinnitus got worse. She was wondering if the Covid vaccine affects the neurological system. She had an appointment to get her second dose of the vaccine and is not sure if she should get it. She wanted to know if she doesn't get the second dose how it will effect the first dose. It was reported that She probably won't answer the phone unless it comes up as a contact. She was getting bombarded by telemarketers. If Pfizer wanted to call they could send a text with a number that she can call. She really doesn't like to get too much mail. She lives on a busy street and is trying to eliminate how much mail she gets. She declined to give her mailing address. She has put this off. She thought that maybe it would fade away, but it's not. If she has to be in some sort of study because of this she would probably cooperate. She asked if the second dose of the vaccine is the same as the first dose. She needs to make a decision quick because her appointment for the second dose is in 30 minutes. She would rather be transferred to Medical Information now. Patient was unwilling to complete the report The outcome of the event was not recovered.
Later in the day on the day he received his shote, he complained about how much his arm hurt.  That evening he got very sick, vomiting so badly he got black eyes.  He did not seek medical attention.  Following morning he was feeling fine, except for the black eyes.
Aftershot, patient developed pain on the side of the body (left) that shot was administered, over left arm, left trunk, and left leg. There was no local redness, swelling, or pain at site of vaccine itself.  The patient was treated with Motrin and ice and resolved after 24 hours.
He said it feels like the flu.; the shot area caused much pain; came the head ac; possible fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included unknown vaccination (had a shot for this maybe 5 yrs ago , some discomfort and after effects). Concomitant products included Herpes zoster (Shingrix).   On 28th January 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms, pain, headache and fever. On an unknown date, the outcome of the influenza-like symptoms, pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and within hours the shot area caused much pain, then came the headache along with possible fever. The shot before with no problem and the first time.
Possible pain, redness, swelling after a few days @ injection site; Possible: tiredness, headache, muscle pain, chills, fever, nausea. Pt was monitored for 15 min post injection, no reactions were observed nor reported; pt did not report he had received vaccine previously; provider informed
Mom called states patient has been having fever of 101 was taken to doctor 1-23-06 started on antibiotic for ear infection - last night fever of 101 and had a seizure was taken to hospital.
Patient received Hepatitis B vaccine from Employee Health on 8/9/13. About 30 minutes following administration, she reports rash and itching. Given diphenhydramine 25mg x 1 in employee health. Given another dose to take if needed later in the day.
After receiving first dose and in the observation room, patient was feeling light headed and nauseated. Patient passed out briefly for 2-3 seconds and slumped in his chair.  EMT was with the patient at all times.  After syncopy episode, patient was alert and oriented. Patient was brought to tent in the supine position and was stable.  Patient was still alert and oriented and given juice.  Dr. looked patient over and determined to be vasovagal episode.  Patient fine 20 minutes post episode.  Patient was monitored until sister came to pick him up. Dr. recommended for patient get vaccine recumbrant in 3 wks for second dose.
Patient's arm become red, swollen and painful. She was diagnosed with a reaction to the vaccination and prescribed prednisone.
Headache, Myalgia, Fever, NauseaVomiting, Swollen lymph nodes; Pain/swelling @ injection site Narrative:
Patient is 17 years old and received 1 Dose of Moderna COVID-19 vaccine
Information has been received from a nurse practitioner who on 10-AUG-2012 reported that due to a malfunction of RECOMBIVAX HB (lot # H010380, expiration date 18-NOV-2014) 5 mcg/0.5ml and VAQTA (lot # 0669AE, expiration date 07-DEC-2014) 25u/0.5ml pediatric dose syringes, an unspecified number of patients had received doses of the vaccine when the syringe plunger came out of the barrel. The reporter did not have any specific patient information available at the time of this initial report, since she reported a product quality complaint. The reporter described the following: "When the person administering the vaccine introduced the needle into the patient's muscle and attempted to aspirate the plunger in order to check for placement of the needle in the patient's muscle rather than in the patient's blood vessel, the plunger plastic rod disconnected from the rubber stopper and came entirely out of the syringe barrel. One administrator may have removed the syringe from the needle and attached a new syringe to the needle that was inserted into the patient in order to administer a dose of the vaccine". The reporter was not certain of these events, nor was she certain of the number of patients effected by this syringe malfunction that she reported. The reporter stated that to her knowledge, none of the patients had demonstrated or reported any adverse effects. No additional information is currently available. On 15-AUG-2012, the reporter stated that 3 VAQTA and 2 RECOMBIVAX HB syringes malfunctioned during patient care of previously noted unspecified patients. No further information was provided. Additional information has been requested.
shingles; This is a spontaneous report from a contactable pharmacist.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot number: Unknown), via an unspecified route of administration on 02Mar2021 as 1st dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient subsequently got shingles. Treatment medication included valaciclovir. The clinical outcome of the event was unknown.   No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Following 1st dose of vax developed fatigue, malaise, & swelling of the joints of rt hand w/arthralgia; Joint pain persisted for one day & the arthralgia of the elbows, hand & knees lasted for approx 3 wks;
Excruciating Headache; Nausea; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        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 details was given.   No Treatment drug details was given by reporter
Received FLUMIST on 10/23/2009, phoned office on 10/27/09 to report a complaint of "pain near her right eye". Explained that has aching around eye socket, side of face tender, skin appears flushed to both R and L cheek/sinus areas client reports. Has been using Ibuprofen for relief. Noted Sx to begin on 10/24/09.
On 5/16/19, approximately 48 hours after administration of vaccine, the client reported area of redness where Varicella vaccine was administered approximately 1 inch in diameter.
AFTER ONE WEEK PATIENT AND HIS WIFE EXPERIENCED AT SITE OF INJECTION REDNESS AND SWELLING WITH BUMPS IN AREA OF INJECTION. NO OTHER SYMPTOMS, AND AREA IS GETTING BACK TO NORMAL
ACUTE DVT, UNSPECIFIED VEIN 12/8/2021 ACUTE DVT OF BILAT FEMORAL VEINS ACUTE DVT OF BILAT FEMORAL VEINS 12/9/2021 ACUTE DVT OF BILAT FEMORAL VEINS ACUTE DVT OF BILAT ILIAC VEINS 12/8/2021 ACUTE DVT OF BILAT FEMORAL VEINS
headache for approx 12 hrs after receiving the vaccine. headache persisted for about 12-6 hours afterwards
Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves
Patient states arm was extremely sore after receiving vaccine about 10-13 days before it was feeling better. Pt. states arm felt numb and was difficult to move and perform activities.