chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 07-MAR-2007, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 02-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
The pt developed light-headedness, dizziness and nausea that lasted 2 hrs.
Dehydration; left arm pain; unable to roll or lift on left arm; diarrhea; gas; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 29May2021 at 09:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not know about her other medical history. The patient was allergic to walnuts. The patient did not receive any medication within two weeks of vaccination. 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. On 29May2021, the patient experienced dehydration, left arm pain, unable to roll or lift on left arm, diarrhea and gas. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events dehydration, left arm pain, unable to roll or lift on left arm, diarrhea and gas were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to "a full of clients" of unknown genders and ages. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The physician reported that on an unknown date, the patients experiencing feeling tired post vaccination with GARDSAIL. The patients did not receive treatment for the adverse event. At the time of the report, the patients' outcomes were unknown. Additional information is not expected.
Sciatica nerve pain throbbing constantly from left butt down left leg to my calf.  Started February 16th, strong pain (just bearable).  Starting February 20th, pain slightly subsided and just painful during walking.  Starting February 22nd (today), slightly less painful. I am hoping this is not permanent...
17 yearold male presented for 2nd shot of moderna, parent notified and signed waiver for client to receive dose. client and father made aware vaccine not approved for under 18 and advised to visit pcp for further consultation. moderna notified. monitored no adverse reaction identified, stable.
Metallic taste in mouth for ~ 30 minutes after shot; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hodgkin's lymphoma (in remission). The patient had no known allergies. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and rosuvastatin calcium (CRESTOR); all taken for unknown indications from an unknown date and unknown if ongoing. 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 vaccination. On 26Feb2021 at 15:15, the patient experienced metallic taste in mouth for approximately 30 minutes after shot. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth for approximately 30 minutes after shot was resolved on 26Feb2021 at 15:45.  No follow-up attempts are possible. No further information is expected.
Pt recvd 1st dose of Hep B vax 06DEC89 & exp nausea,weakness & lethargy.Pt. recvd 2nd vax 05JAN90 & devel chills,upper rt quadrant pain & nausea.05FEB90 devel rash on back w/ Pruritus.
102.4 temperature, body aches, headache that lasted 3 days, chest discomfort, and smell and taste sulfur all day. The sense of smell and taste of sulfur is still occurring a month later. On and off chest discomfort since vaccination also. Shortness of breath occurred for 5 days after vaccination.
Headache, Arthralgia, fatigue, chills, injection site pain Narrative:
Vaccine was administered to a 13 y/o child. J & J vaccine is not approved for individuals under age 18 years. Mother was contacted to determine if the child experienced any adverse effects from the vaccine on 1) the day of the clinic, and post vaccine day 1 and 2. Mother denied that the child experienced any adverse effects from the J and J vaccine.
This spontaneous report as received from registered nurse refers to an approximately 2 months old patient (reported as 2 months and 10 days, gender not reported). Nurse reported that an expired dose of ROTATEQ lot #0210AE (exp. date 29-SEP-2013) (route and dose not reported) went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several reports from the same source (MARRS # 1310USA006562, 1310USA006563). Additional information has been requested.
Itchy rash developed in the early afternoon on injection day.  Rash persists and got worse four days later.  Rash began on upper arm of injection site and spread throughout the body including both upper arms and forearms, shins, calves, side of torso
4MAY92 pt recvd vax 5MAY92 noted stiffness in back of neck on lt side; pt noted numbness of upper lip progressing to lt facial numbness/weakness; 6MAY92 c/o eyes feeling dry; 6MAY92 to ER dx bell's palsey;
Jan 14 2022, developed sore throat, extreme tiredness, aches and pains and general feelings of illness. Symptoms continued, also developed stuffy nose, hearing loss, lightheadedness. Ten days later, I spoke to my doctor via phone and she made an appointment to see me. I went to her office, and she checked me. She said she was sure I had COVID because I presented with all symptoms that they had been seeing. She prescribed Zyrtec, Nasal spray Fluticasone, and Mucinex., with lots of water and rest.
Developed tinnitus in both ears 12 hours after vaccine; Other vaccine same date product: Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 21Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Sulfa antibiotics allergy" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: CHOLESTYRAMINE. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. Vaccination history included: Pfizer (Prev dose dose number=3, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration time=14:00 PM, Prev dose vaccine location=Left arm), administration date: Sep2021, when the patient was 51 years old, for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 21Oct2022, outcome "unknown", described as "Other vaccine same date product: Flu"; TINNITUS (non-serious) with onset 22Oct2022 at 09:00, outcome "not recovered", described as "Developed tinnitus in both ears 12 hours after vaccine". Therapeutic measures were not taken as a result of tinnitus.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Seriousness criteria was reported as no.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
LYMPH NODES IN MY RIGHT ARM (RIGHT ARM PIT) HAVE BEEN HURTING A GREAT DEAL; This spontaneous report received from a patient concerned a 70 year old male.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Dose number series was 1. No concomitant medications were reported. On 11-NOV-2021, the patient experienced lymph nodes in my right arm (right arm pit) have been hurting a great deal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from lymph nodes in my right arm (right arm pit) have been hurting a great deal.This report was non-serious.
Extreme pain in upper arm (point of injection) for 3 days, then redness and swelling for next 4 days, fatigue for 3 days (I took Hydrocodone, TYLENOL and Ibuprofen).
Second shot - headache, body ache and chills for 36 hours. I used Ibuprofen and rest.
Patient was really nervous prior to the vaccine being given. After vaccine given. Pt walked out to waiting room and fainted fell and hit her head on car seat. We advised pt to lay down, ice on head and gave some water and crackers.
Received second dose around 3:30pm on June 11 2021. During the night woke up several times feeling ill. Developed  symptoms that lasted all day on June 12th. HORRIBLE Headache, Fever of 100.7. Chills, body aches, stiffneck. Injection site was sore swollen warm and red. Symptoms faded on June 13th leaving me feeling weak. Developed sweats on and off on June 13th. It took 3 days for me to start feeling more like normal. Injection site took a week to get better. I used Advil to help relive symptoms but it did NOT help the headache.
Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 929901) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction. Concurrent medical conditions included Latex allergy since 01-Jan-1994 and Urticaria.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 11-Sep-2021 to 14-Sep-2021 for Adverse event, at a dose of every 4 hours and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]) (oral) on 13-Sep-2021 for Adverse event, at a dose of 4 mg. On 13-Sep-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.            Concomitant medications were not provided. Additional treatment included-oxygen. Company Comment:  This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 17-SEP-2021 and patient demographic updated, event were added, product tab information added,  medical history added and treatment medicines added.; Sender's Comments: This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.
affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 25Mar2021 10:00 (batch/lot number EP6955 and expiry date not reported) at 77 years of age as single dose for covid-19 immunization in a clinic facility and not in military facility. Medical history included Stroke from 2014 and another in Dec2018; the patient had MRI to confirm, ongoing blood thinner (therapy). Concomitant medications included rivaroxaban (XARELTO) taken for blood thinner from Jan2019 and ongoing. The patient previously took first dose of bnt162b2 on 04Mar2021 at 77 year of age for covid-19 immunization and experienced arm soreness, Eliquis for 2.5 years after the first stroke for blood thinner and couldn't deal with Eliquis very well and made her feel like she was dying. The patient had no prior vaccinations (within 4 weeks). On 30Mar2021, the patient experienced TIA (transient ischaemic attack). The patient informed that at first she had nothing then five days after the second dose (30Mar2021), she had a TIA. The TIA that she experienced was so sudden and so alarming. It affected her balance and walking (unspecified date). The patient informed that when she was walking to pick up a stick she felt out of balance. The patient was walking like she was a drunken sailor and was staggering. It was the oddest thing. The patient has not talked to her doctor. The TIA was quick then it was gone. It was scary. The patient did not seek treatment (no treatment received). The outcome of the event TIA was recovered on 30Mar2021, while unknown for the rest of the events. The patient considered that the TIA may have had nothing to do with the shot, it happened 5 days later.
24 hours after injection started with fatigue, shortness of breath, insomnia.shortness of breath continues 1 week later. winded even with conversation. some congestion in head on and off.
She has a red, slightly raised area at the site office shingles vaccine. The next day she had vertigo when she woke, she also has nausea. The local area is slightly warm and irritated.
Bell's Palsy- received flu vaccine 11/11/05 - developed Bells palsy 11/16/05-  negative lyme titers and EBV titers
Fever, Sweats, Chills, Nausea, severely swollen lymph nodes with soreness under left arm, neck, and shoulder blade.  Swollen nodule at base of neck near left shoulder.  Achiness in knees and elbow joints.
Patient's mother states that patient had been sleeping a lot since vaccines. Also states patient's (L) leg is red, hot to touch & swollen and patient has temp of 99.9. Instructed to continue TYLENOL and to use ice packs on leg.
Atrial fibrillation; Horrible symptoms and bad reaction that I am suffering; they thought I was drunk; I slept all weekend long 2 days; Chronic fatigue; it is a lot worst not going away; Horrible symptoms and bad reaction that I am suffering; they thought I was drunk; I slept all weekend long 2 days; Chronic fatigue; it is a lot worst not going away; Horrible symptoms and bad reaction that I am suffering; they thought I was drunk; I slept all weekend long 2 days; Chronic fatigue; it is a lot worst not going away; Nauseous; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication, start and stop date were not reported. When probed for the concern, consumer stated, she just wanted to report her horrible symptoms to this (Pfizer Covid-19 Vaccine) which was given to everybody because she thought did but it looks like they probably have not. On 01May2021, the patient had atrial fibrillation, Horrible symptoms and bad reaction that I am suffering; they thought I was drunk; I slept all weekend long 2 days; chronic fatigue; it is a lot worst not going away and nauseous. Her heart raised and she was weak. She stayed there out of the place because they thought she was drunk; she slept all weekend long basically and later found out that she went into (Atrial fibrillation) because of that. Patient took her first dose vaccine on 01May2021 and she didn't take the second dose they doctor advised her. She just gave the symptoms, that's all she wanted to do, she slept all weekend long 2 days, her heart was raised, and she was weak, she was dizzy, she was nauseous, she has like chronic fatigue and she went into (Atrial fibrillation). Consumer was informed about the role of Pfizer Drug Safety. Consumer stated that she went into Atrial fibrillation, it was the most important thing because she does not think (Hence, documented MI) they were reporting that correctly, the other symptoms everybody seems to get but her intent was a lot worst because it was not going away. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Pain in body; Weakness; Pain in administration area (Right arm); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Apr2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: Pertinent details: Continuous use medication (Prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EP7534, Route of administration: Intramuscular, Time of vaccination: 14:00, Dose no: 1), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Pain and inflammation of the administration area (left arm)", "Pain and inflammation of the administration area (left arm)", "weakness". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in body"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in administration area (Right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:2nd dose: Pain in body and weakness. Pain in administration area (right arm). The effects disappear after 3 days.   Follow-up attempts are completed. No further information is expected.
My son was given 0.5 ml instead of 0.25 ml of the flu vaccine so double the dose for his age-not sure which vaccine it was so in item 17 I was guessing based on the info from my son's medical chart available. When the doctor's office notified me via a message from a nurse, I attempted to call back and was unable to reach them. I went to the office directly and spoke with nursing staff and then Dr. who said he didn't understand why I was upset since "this wasn't chemotherapy just a flu shot" and that "this kind of thing doesn't happen often but it does happen so it is unfortunate it happened to us". This is the not the first concerning thing that has happened with regard to the care of my children in this practice and I believe it should be investigated. Upon calling poison control I was told to watch for a reaction for the next 24 hours, so far my son seems fine but 24 hours will pass at 6:30pm tonight.
Sore arm as usual which is normal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm as usual which is normal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-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 (Sore arm as usual which is normal). At the time of the report, PAIN IN EXTREMITY (Sore arm as usual which is normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.