chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a doctor's office staff concerning a 49 year old female with no drug allergy and no medical history who on 17-NOV-2010 was vaccinated IM with PNEUMOVAX 23, 0.5ml (lot # 667692/1110Z). Concomitant therapy included ADVAIR, aspirin, cephalexin, cyclobenzaprine HCl (MSD), gabapentin, hydrocodone, acetaminophen, multivitamin, naproxen, PORTIA and ezetimibe (+) simvastatin (MSD). Within an hour or 2 (17-NOV-2010) the patient experienced significant pain, redness, swelling and it hurt to move her arm. When the patient called the office on the next day she thought the symptoms were about the same as the night before. She also had a low grade temperature. Lab diagnostics studies were not performed. Treatment given for the vents included ice packs and antihistamine. The patient had sought medical attention by phone. At the time of reporting, the outcome was unknown. It was unknown if the patient received PNEUMOVAX 23 in the past. Additional information has been received from a physician's office concerning a 49 year old female with low back pain, ventral hernia, irregular menses, a family history of breast cancer (mother), osteoporosis and hypertension, and past history of cholecystectomy (1985) and vaginal delivery (1994). It was reported that the pt received a flu vaccine, split (manufacturer unknown) in October 2010 and that the patient had received a prior does of PNEUMOVAX 23 (no date provided). On 17NOV2010 pt received a dose of PNEUMOVAX 23 intramuscularly in the left arm. On 19NOV2010 the pt saw her physician for her reaction to PNEUMOVAX 23 which included significant pain, then swelling and redness. She had significant erythema and induration going down from the mid arm to upper forearm encompassing the elbow and down to wrist. She had good flexibility of the joint. Assessment was a nonvesicular rash. The physician marked the area with a pen and advised patient that the area should not get any larger. If worsened, the patient needed to be seen. The physician reported that the patient recovered on 26NOV2010 and that she had "received 1 prior dose of PNEUMOVAX 23 and she should not receive any more". This is one of several reports received from the same source. Additional information has been requested. All medical records will be provided upon request.
Nodule at the bottom of his bladder; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Nodule at the bottom of his bladder) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included Prostate cancer (5 years ago).    On 12-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced NODULE (Nodule at the bottom of his bladder). At the time of the report, NODULE (Nodule at the bottom of his bladder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: PSA was creeping up and it finally went up to 0.5..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  Patient found a nodule at the bottom of his bladder and he is going to undergo radiation treatment in 2 weeks time. Patient stated that 5 years ago he had a prostate cancer that was removed.  Patient received Moderna COVID-19 vaccine first dose on 18Feb2021, lot number  031M20A, second dose was on 18Mar2021, lot number - 001B21A, third dose was on 28Oct2021, lot number - 058F21A, 4th dose was on 30Mar2022, lot number - 048L21A.
One week following the 3rd dose of Lymerix, the pt experienced flu-like symptoms, myalgias and arthralgias.  The most recent information received on 9/3/99, reports the pt made a full recovery.
arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications were not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-075385 (Patient Link).
Chills in the initial 24 hours, followed by arthralgias which have diminished, but are still present three months later.
extreme physical and mental fatigue; malaise (feels like 24 hr flu 7 days a week for moths); shortness of breath; headache; cognitive disfunction; light source sensitivity; body on high alert; continuous anxiety; panic attacks; exercise intolerant; malaise (feels like 24 hr flu 7 days a week for moths); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme physical and mental fatigue"; MALAISE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "malaise (feels like 24 hr flu 7 days a week for moths)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive disfunction"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "light source sensitivity"; HYPERVIGILANCE (non-serious), outcome "unknown", described as "body on high alert"; ANXIETY (non-serious), outcome "unknown", described as "continuous anxiety"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "exercise intolerant".  Additional information:Follow-up (01Nov2021): The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 01Nov2021, this case now contains all required information to be considered valid.Exercise intolerant - Minor execise results in crash and Tsunami.My life is horrible! Understand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Titer was low; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 35-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Engerix B. On 6th February 2020, the patient received the 2nd dose of Engerix B. On 7th July 2020, the patient received the 3rd dose of Engerix B. On 26th August 2020, 230 days after receiving Engerix B, 202 days after receiving Engerix B and 50 days after receiving Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist patient received the Engerix series and titer was low and might had the series repeated.  The reporter consented to follow up.
Client was administered a higher than recommended dose of the Bivalent Pfizer Covid Vaccine. The error was immediately noted and she was closely monitored following the vaccination. The only reported side effect was itching at the site of administration 45 minutes after administration, for which she was given diphenhydramine with good effect. This error has been reported to the proper agencies and we are taking steps to ensure something like tis does not happen again.
Tested pos. on 01/02/2021; loss of smell and taste, sinus congestion;1/15 chills, felt nauseous & dizzy, fatigue, dehydrated. Slept 19 hrs, had 2 IV's. 1/16 Spiked fever of 102.3, vomited multiple times x two days. 1/17/2021 had IV therapy tx at home with vitaminC, glutathione , zofran. Had scopolamine patch, phenergan, zofran for nausea. BP dropped 90/52. Breathing tx of Xopenex and Budosemide, O2 sats 92 or above1/18/21 went to ER for chest x-ray, all clear1/23/2021 another IV. Started omnicef and doxycycline & dexamethasone ,99.9 fever, more vomiting, on bland diet, malaise and anorexia/n/v;1/24 IV,1/26 labs 1/28-29 CT scans,1/28 Ivermectin; 1/30 vomiting/ IV, 2/10 Hydroxychloriquin and Ivermectin started. #18 Feb 3 Saw GI Dr, given Carafate, probiotics , Nexium.  Returned to work 2/8 still on zofran and scopololamine. 2/25/21 Colonoscopy performed . clear scope with one minor diverticullum spot. EGD also clear. Nausea and fatigue continued through May,2021. October,2021  had a delayed anaphylactic reaction to Sulfa antibiotics for an infection. Had to receive nausea medication, IV therapy, Epinephrine shot, and took Pepcid and Benadryl for a week until hives subsided.
Tingling in hands and feet; Tinnitus in left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jun2021 10:45 (Lot number: EW0202) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 30Jun2021, outcome "not recovered", described as "Tingling in hands and feet"; TINNITUS (non-serious) with onset 30Jun2021, outcome "not recovered", described as "Tinnitus in left ear". The events "tingling in hands and feet" and "tinnitus in left ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of paraesthesia, tinnitus.  Addition information: Facility type vaccine was pharmacy or drug store. Patient did not take other vaccine in four weeks and other medications in two weeks. Patient had COVID prior vaccination, patient did not test COVID post vaccination and known allergies was mentioned as none. Reporter stated that, Pfizer product did not have a casual effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
No known adverse effects; The patient received a dose of VARIVAX via the intramuscular route in error; This spontaneous report was received from a pharmacist referring  to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions was provided.       On 17-JUL-2019, the patient was vaccinated in with varicella virus vaccine live (oka/merck) (VARIVAX) one dose, intramuscularly, lot # N022995, expiration date 23-AUG-2019, for prophylaxis (strength, and anatomical site of administration  were not provided) in error (incorrect route of product administration).  No adverse events were reported.
painful blistering rash and was diagnosed with herpes zoster; This spontaneous report was received from a lawyer and refers to an elderly female patient (pt) of unspecified age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 20-OCT-2012,  the pt was vaccinated, at a local pharmacy, with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (previously prescribed by a healthcare provider) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date (reported as "subsequently"), the pt experienced a painful blistering rash and was diagnosed with herpes zoster. The pt was treated (unspecified) by a provider. At the repotting time, the outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX). Loss of consortium was filed.
P/receiving Influenza vax, pt devel severe erythema, induration, edema, & itching @ inject site; rx area was 10-20 cm in size;
LIGHT HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headache. This report was non-serious.
Fever at 101 evening after shots given which continued to 6-30-10 at noon and was treated successfully with ADVIL. Redness to (L) arm from above elbow to shoulder with some warmth but no pain. Some swelling to (L) arm.
Vaccinated between 12: and 1:00pm on 11/13/03.  On 11/14/03 around noon, began to get a sore throat, got progressively worse that day; 11/15 developed fever, sleepiness, dizziness, throat congestion; today (11/16) have all same symptoms plus feeling faint, have  body aches, and "cold symptoms" including bad headache, nasal drip, and upper respiratory congestion including wheezing.  (NATURALLY THIS WOULD HAPPEN ON THE WEEKEND, CANNOT CONTACT THE CLINIC)... taking OTC cold medications.
Patient complained of right upper arm discomfort, redness and swelling beginning approximately after vaccination. Area is at right upper arm moving laterally and is red, hard, tender to touch and edematous. Treated with Ibuprofen 600 mg & Benadryl 25mg IM and 25mg PO PRN and ice. Treated and discharged.
After the vaccine booster, I started experiencing low-grade sporadic headaches that can occur at any time, but more often in the evening. The headaches last for about one hour, but sometimes recur later in the day. This is very noticeable to me, because never have headaches. The headaches continue to occur as of today (10/8), which is one full month after the vaccination.
Very weak for about a week "worsening of multiple sclerosis"; Very weak for about a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") in a 74-year-old male patient who received mRNA-1273 (batch nos. 001B21A and 006M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included WARFARIN, METOPROLOL, OXYBUTYNIN and LEVOTHYROXINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") (seriousness criteria medically significant) and ASTHENIA (Very weak for about a week). On 20-Mar-2021, MULTIPLE SCLEROSIS (Very weak for about a week "worsening of multiple sclerosis") had resolved. At the time of the report, ASTHENIA (Very weak for about a week) outcome was unknown. Unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. No treatment medications were reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. 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.    Sender'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.
Patient reports uncomfortable pain throughout entire body including hair, skin, joints, muscles. She can't move without feeling the discomfort and even resting her legs on a pillow triggers the pain where her legs touch the pillow.
Patient's daughter called day after vaccines to report that patient was experiencing head to toe to pain like she had never had before. She also got a flu shot elsewhere before getting Abrysvo and Spikevax from us.
22 hours after vaccine severe lower back ache followed by fever and feeling unwell. Woke up the next morning with fever gone but severe lower back ache that made it so.I.could not sit or walk. I had to have my family purchase a walker so I could get to bathroom and back to bed in extreme pain. 8 days later I was finally able to.make it to the Dr and given steroids and anti spasm medication. X rays revealed nothing, all muscular. Massage therapist seen on day 10 and received a lot of relief. The following 5 days continued improvement but limited movement, cant bend limited activity, but feeling better.
Patient came in for 2nd dose of Shingles Vaccine, patient received vaccine at about 1:10pm and was  advised to wait 15 min in case of adverse reaction, while waiting in the lobby patient informed receptionist she was having a lot of pain. I approached patient and asked her about her pain, patient stated that her left arm was feeling numb as well as her left leg and indicated that her back (shoulder blade area) was hurting which radiated to her lower back. Patient was brought back at about 1:15pm and Dr. was called to triage patient. 4 sets of vitals were taken 151/87  pulse 87 at 1:15pm, 142/86 pulse 92 at 1:25pm, 142/82 at 1:35pm, and 133/82 pulse 91 at 1:40pm with O2 sat of 96% and temperature of 97.6
VOMITING X SEVERAL HOURS THE NIGHT AFTER SHOTS WERE GIVEN THAT SAME DAY.  SELF RESOLVED BY NEXT MORNING
Myalgia, Fever, sore throat, chills, night sweats Narrative:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-DEC-2008, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 30-NOV-2017, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
13 year old male client who received 3 Gardasil 9 doses at 0-6-18 month interval; This spontaneous report has been received from a physician concerning a 13-year-old male patient. The patient's concurrent conditions, medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On unspecified dates, the patient was vaccinated with the three doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical site of vaccination were not provided; lot number and expiration date were unknown by the reporter) as prophylaxis. The patient received the doses of the vaccine at an interval of 0, six and eighteen months (inappropriate schedule of product administration). The physician requested information regarding this patient.
PT WAS GIVEN A HIGH DOSE FLUAD AT AGE 64 AND SHOULD HAVE BEEN GIVEN A STANDARD QUADRIVALENT VACCINE
Patient had acute fever, mild chest pain and tachycardia about 12 hours after vaccine. Since then she has had mild chest pain, fatigue, lymphadenopathy
Female patient without chronic conditions. Does not use medication. Within 10 minutes  of MODERNA vaccination refers to paramedic feels dizzy. He proceeds to take the patient to the area of the stretcher where she says that she has a heater in her body. Vital signs were taken, BP 140/70m, 99 SAT, temp 36.0, dextrose 110. She was kept under observation and at 30 minutes she indicated that she had chills and proceeded to call 911 so the patient was transferred to the hospital.