chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild headache; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 13:00 (Lot number: EP7534) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE SODIUM.  The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain in the arm". Additional information: There was no other vaccine in four weeks. Other medications in two weeks included Levothyroxine 112 mcg. For the first shot patient had a mild headache and pain in the arm for three days after the shot. The patient did not had covid prior vaccination and not tested covid post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
About 30 minutes after vaccination, patient states that he experienced numbness/tingling in both legs from above the knee down to an in his feet. Sxs continue to date.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/16/2022,  7/12/2022,  8/17/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Felt ill the day after vaccination. 2 days afterwards noted red blotches R arm especially around proximal injection site. Fever to 103.3 documented about 60 hrs after injection, seen in ED, treated with IV hydrating Toradol, Keflex, KCL, cellulitis or cellulitis like picture.
She felt the loss of strength on the right-side of her body, from arm to leg. She was standing and almost fell because of that. She moved her arms around immediately and finally "woke" them up. It took much longer for her leg to return to normal (after massaging the whole leg). This incident lasted about a half-hour. We are closely monitoring her and will go to the hospital if this happens again.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 28-MAY-2015, a physician at a clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On 11 and 26-JAN-2017, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
01/25/22 presents to ED for "cough and shortness of breath". PMHx of "Non insulin dependent type 2 diabetes, HTN, Dyslipidemia"
This spontaneous report was received from a health professional via field representative refers to an 11 year old male patient. Patient's pertinent medical history and drug allergies were not reported. On 23-MAR-2015 the patient received his first dose of GARDASIL, .5 ml, intramuscular in the arm. Concomitant therapies included DTAP (unspecified) and MENACTRA. Within six hours of receiving the vaccination with GARDASIL, the patient experienced pain, warmth and swelling the size of a softball at the injection site. During the same office visit, he also received DTAP (unspecified), and MENACTRA in the opposite arm and experienced the same reaction at the injection site. Patient sought medical attention and visited physician's office on 23-MAR-2015. After assessing the patient, physician decided to discontinue the GARDASIL vaccination series and the therapy was not reintroduced. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
10 day p/receiving MMR/HIB/OPV pt devel fever of 105, limpness, pallor; pt recvd APAP; Seen by ER MD dx ear infect; was febrile & weak x 4 days;
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: The patient appeared shaky and disoriented after given the Pfizer vaccination.
Vaccine administered at approx. 10h30AM. Call from daughter at approx. 4h10PM reporting patient vomiting and unwell. Patient referred to MD or hospital ER.
Flu-like pain; temperature - 99-100 degrees; itching skin; sick to stomach - vomiting until following morning. (BENADRYL taken day after to relieve itching).
All typical symptoms fever, diarrhea, nausea, chills, body aches, stiffness and fatigue the day after the vaccine.  Breathing issues started 3 days after the vaccine and took me to the emergency room on day 5 after vaccine.  I could not get a full breath and felt very tight in my chest and throat.   On day 6, my pulmonologist said it was a flare up of asthma and COPD.  He added an antibiotic to the and nebulizer treatments along with the steroids prescribed at the ER the night before.
HCP reported that a 15 year old received their second dose of the vaccine on 04/04/2024 and seen 3 weeks later for cellulitis. The cellulitis developed on the same arm were the; This spontaneous report was received by customer and refers to a 15-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On unspecified day in April 2023 (reported as 3 weeks later), the patient experienced vaccination site cellulitis. The cellulitis developed on the same arm were the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (also reported as: GARDISAL 9) was injected. The outcome of vaccination site cellulitis was unknown.  The causality assessment was not provided.
Pt. received SHINGRIX on 3/22/19 IMRA; pt developed red rash with itching over weekend-Pt reported reaction to pharmacy on Monday 3/25/1 - pt took BENADRYL over weekend - This was the 2nd dose; there was no reaction like this after 1st dose SHINGRIX photos included.
PATIENT EXPERIENCED A RED BRUISE ON HER ARM BEGININNG THE DAY AFTER HER IMMUNIZATION. SHE STATED THAT HER ARM WAS SORE, BUT THE SORENESS WENT AWAY AFTER 24 HOURS. THE ONLY REMAINING SYMPTOM SHE HAS IS THE BRUISED ARM AND IT WAS PRESENT AS OF 9/28/2022.
This spontaneous report was received from a registered nurse via company representative regarding a 61 year old female patient with asthma, hypertension and coronary heart disease. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number were not reported). On 12-NOV-2014, the patient experienced a large extended rash. On 13-NOV-2014, the patient had an appointment at doctor's office and was treated with unspecified antibiotics. The outcome of a large extended rash was not reported. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Patients was suppose to receive Moderna not Pfizer. Patient was notified and an attempted was made to notify PCP.
right arm felt so heavy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to the company on 25-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (right arm felt so heavy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced LIMB DISCOMFORT (right arm felt so heavy). At the time of the report, LIMB DISCOMFORT (right arm felt so heavy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Pharmacist at Store on October 8th, 2021 administered Menactra to patient above 55 y.o. after patient stated she was traveling overseas later in the year. During administration, the vaccine squirted out and it is unsure if the patient received any or some of the vaccine. It appears the needle wasn't tightened. Patient care pharmacist are working on getting more information from the patient's primary care provider and Menactra manufacturer on whether she should be vaccinated in the future in the case of underdose.
Stroke; numbness in left hand; Headache; Ataxia left arm,; Motor skill issues/steadiness, unbalance; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATAXIA (Ataxia left arm,), BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand). The patient was hospitalized from 25-Jan-2021 to 26-Jan-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved, ATAXIA (Ataxia left arm,) and HYPOAESTHESIA (numbness in left hand) had not resolved and BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on an unspecified start date the patient is currently in OT.  Treatment information not reported.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received by safety 10-Jun-2021 included  an ADR added. Reporter address is updated. Patient height, weight, race and ethnicity is captured. Information of first and second vaccination updated. Event information was updated. new events, stroke and ataxia in left arm added and the events led the patient to visit ER.; 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.
Moderna Covid 19.   01-09-2021.        Moderna 02-06-2021. Moderna Booster  11-03-2021.      Tinnitus?very loud after Booster?sounds like hot summer night cicadas.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced Guillain Barre Syndrome (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to Influenza vaccine Quadrivalent unspecified. Additional details were provided as follows: This case was received from patient's son in law. The brand name and manufacturer of the flu vaccine was unknown. The event occurred years before the date of reporting, specific date was not provided. The reporter declined to proceed with safety report. This case has been linked to the US2018025095, reported by the same reporter.
Patient of 14 years of age, one day after her third booster of the dose of PFIZER 0.3ml, the same, Around 7:00am, she presented, vomit, paleness, dizziness and sweating. The parents called the 911 service and she was transported to the hospital where she was hydrated.
Information has been received from a physician concerning her 13 year old daughter, who, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced a headache, and "heavy limbs" whereby it "hurt to move legs." The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report was received from a registered nurse and refers to a 59-year-old male patient. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). The patient was allergic to penicillin and amlodipine besylate (NORVASC). Concomitant therapies included clonazepam(CLONOPIN), fluticasone furoate (+) vilanterol trifenatate(BREO), acetaminophen(TYLENOL), albuterol, buprenorphine hydrochloride, naloxone hydrochloride(SUBOXONE), doxepin hydrochloride(SINEQUAN), levetiracetam(KEPPRA), lisinopril, sertraline hydrochloride(ZOLOFT), chlormezanone(RESTORIL), tiotropium bromide(SPIRIVA) and unspecified medications. On 18-JUL-2018, the patient was vaccinated with first dose of PNEUMOVAX 23 for prevention of pneumococcal infection (dose, route and lot # was unspecified). On 30-OCT-2018, the patient was inadvertently vaccinated with second dose of PNEUMOVAX 23 (dose and route unspecified) from lot# N013521, expiry date: 23-JAN-2019 (incorrect dose administered). On the same day evening, the patient developed "pink around area of injection site, his arm was warm to touch, there was swelling around radius of arm near 80% around the arm and possibly cellulitis" (injection site cellulitis, injection site swelling, injection site warmth, injection site erythema). No treatment was provided for the events. The outcome of the events was reported as not recovered. Causality assessment for the events was not reported. No product quality complaint was involved.
Tingling lower lip, itching for 3 days after the vaccine took Benadryl at home
Pt. stated arm was swollen (size of softball) at injection site for 1 1/2 wks. Continues with dull pain in arm. States onset of sxs occurred 24hrs. after inj. given with low grade temp & pain at inj. site. States low grade temp & stomach discomfort persists. Has not followed up or been seen since.
Hives 4 days after the Janssen vaccine. She had a similar reaction to the flu vaccine in the fall of 2020.
That evening I had a headache and I was achy. After going to bed I developed chills where I couldn't get warm and I was shaking, and then it turned to sweating. The next day I was weak, achy, nauseous. That night I developed a fever too. My injection site it still warm to the touch and a little red and swollen, but is looking better. I also had stomach pains in the evening Friday and Saturday night that happened when I was nauseous too.
Persistent arm pain, weakness, feels like an injury.  Left shoulder and wrist.  Rested for 2.5 weeks and the pain subsided some but still remains (1 month so far).  Difficulty sleeping on left side.
On the night of receiving the vaccine, patient experienced tightness in her chest which was relieved after taking a couple of puffs of ventolin inhaler. During the course of the night symptoms included freesing, shaking, painful eye sockets, headache, major sweat and painful skin all over. She felt better by noon of next day.
Chills, fever, redness /rash, hot skin, hardness of skin, pain/soreness.
Registered pt and asked her all required questions. She was asked if she had received any other Covid vaccines and she stated no. Upon checking FL shots, I discovered she had received Pfizer on 03/26/2021. When asked she stated again stated no but when pressed further she stated that she had been a part of Pfizer program and that she was part of a program and was given a  placebo but later was given the actual vaccine. Unfortunately I don't have a phone number to contact her directly for any side affects.
A dull but loud ringing soud suddenly began in my left ear around 7 pm on August 31, 2021. I've had occasional tinnitus in both ears since around April 2019. The ringing had always previously been very light. On the evening of 8/31/21, a dull but loud ringing suddenly started in my left ear. It has been mostly persisten since that time with occasional, brief periods of no ringing. Prior to the onset on 8/31/21, I had not experienced any ringing sound in either ear for several days.
joint pain; difficulty concentrating; severe fatigue; Headache; body aches; low-grade fever; This is a spontaneous report from a contactable nurse. This 54-year-old male nurse reported for himself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) at single dose for COVID-19 immunization on 15Jan2021 at 15:45.  Relevant history included HTN (hypertension), hyperlipidemia, alopecia, seasonal allergies, obese and covid prior vaccination. Relevant concomitant drugs were unknown. No Known allergies. The patient experienced headache, difficulty concentrating to start followed by joint pain, body aches, low-grade fever, and fatigue on 15Jan2021 at 17:30. The next date the patient had severe fatigue. The next 2 days better when first awake then headache, fatigue after about 4 hours. Treatment therapy for the event was received. The outcome of event was recovering. The patient  did not have other vaccine in four weeks. The patient did not have covid test post vaccination.
mom reports swollen rt arm @ inject site & pt c/o w/movement of arm, 4-6 hrs post vax; RN advised cool packs & APAP every 4 hrs x 24, then warm packs; see pvt MD if not better or worsens; mom reports went to ER for convuls & fever-100.6;
pt called clinic 11JUN96 to report inc redness to lt arm where vax given;had fever, pain, swelling & redness spreading from shoulder to elbow;also c/o malaise feeling called MD office & started on DPH, COrtisone cream & ice;
I woke up at 3:42 am the night after my second dose and my airway was completely closed.  i was unable to inhale or exhale.  I panicked and forced by breath as hard as I could.  I was able to take a partial breath and after approximately 30 seconds I could breath again.   At approximately 4:15 am I woke again with the same experience.  It was not as severe the second time, but still quite alarming.  The sequence of events was similar.  During both episodes I feared for my life.   I have not had this experience ever before or nor since these two episodes.
Severe pain in upper arm even if there was no contact or movement. As of 10/1 11AM, the pain is still there, but only when I raise my arm. Severity has decreased. Headache that began around 7PM that didn't fully resolve until around 9AM the next morning
Right anterior thigh with a 6-7 cm area of erythema, slight warmth to touch, and slightly indurated.
Patient stating that she is having a lot of pain in her right shoulder.  Mentioned that she thought when the vaccine was administered we "hit a nerve" and she could feel it in her hand.  Also received a flu shot in the other shoulder that she says is fine but experiencing a lot of pain in the arm we administered Prevnar.
This spontaneous report was received from a immunisation official and refers to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (lot # L044056, expiry date: 02-MAY-2017, route of administration not reported). The temperature excursion range was between -14°C to -10°C within 1 hour. Data logger was involved. No adverse effect was noted. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009918: US-009507513-1703USA009917:
Patient was 15 at time of vaccination, not 16. Patient's mother filled out his consent form and stated he was 16. Patient received first dose of Pfizer covid-19 vaccine and had no side effects or adverse reactions reported by the mother to date. Patient's mother was notified to report any adverse reactions. His second dose appointment was cancelled.
Severe body aches  Fever 103-103 Fahrenheit Vomiting  Diarrhea  Severe headache