chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant via company representative and refers to a 25 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 30-JAN-2017, the patient was vaccinated with GARDASIL 9 injection, lot # M028323, expiration date 26-SEP-2018 (strength, dose and route of administration were not reported). On 30-JAN-2017, after the  the patient experienced blotching and discoloration on her hands off and on for fifteen minutes. The medical assistant advised the patient to take diphenhydramine hydrochloride (BENADRYL) when she got home. No product quality complaint was involved. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact physician.
Pt. admitted to medical ctr for leg swelling, facial swelling/erythema, and diffuse body rash a few hrs. after 2 mo vaccines - presumed vaccine reaction.
Wrist swelling that lasted about 2 days. 1 week later the shoulder started swelling, redness, severe pain that extended to the arm and the hand. limited mobility on the entire arm and hand.
pt recvd vax 19SEP95 & 3OCT95 saw MD d/t onset of fever & rash over entire body, CBC lab drawn, phenergan supp rx given, saw MD again on 10OOCT95 & was cleared to return to work;rash almost completely gone very very few areas noted
Tingling and numbness of entire arm  from top of shoulder to fingertips (in same arm that received injection). 90% loss of feeling. Nurse on site said this was normal. Subsided slightly after 30 minutes, but two hours later spread to armpit and surrounded underarm area about 3-4 inch radius. Persisted for three days after injection of second dose.  Other symptoms included extreme fatigue, headache, muscle pain, low grade fever, loss of appetite.
Steadily increasing muscular pain starting in the area of where I got the shot (left shoulder) and extending into the neck and torso area.
Initial unsolicited report received from a consumer via other company (Pfizer) on 17 December 2015. Manufacturer report number: 2015137326. This case involves a male patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date (two weeks ago). The patient also received a 100 mg of VIAGRA one in 3-4 days as needed on an unspecified date. The patient ongoing taking VIAGRA. The patient medical history reported as disability. The patient was disabled before starting VIAGRA. Concomitant medication was not reported. On an unspecified date (may be a week and half ago), following the vaccination, the patient experienced congestion in his lungs and sore throat which was later diagnosed with acute bronchitis. The patient got 10 day supply of Antibiotics which he finished on an unspecified date (yesterday). It was reported that, the patient do not work right now he hurt his back like 4 years ago. The patient received VIAGRA 100 mg and he stated that he has Walking Pneumonia and he is currently on antibiotics. Laboratory investigation was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. The patient was not recovered from events. Upon internal review, company assessed the event of acute bronchitis, sore throat and congestion in lungs as serious and important medical event. List of documents held by sender: none.
acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now; acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now) and NEURALGIA (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Neuropathy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INFLAMMATION (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now) and NEURALGIA (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now). At the time of the report, INFLAMMATION (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now) and NEURALGIA (acute pain and inflammation of their nerves, they are painful all over their body, and they have not  being in so much pain in over a year. The pain has being steady for over a week now) outcome was unknown. Not Provided          No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-055514 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-055514:Cross linked with first dose
Started upon awakening with feet and hands feeling numb and tingly.  Also started with headache described as behind his eyes.  Seen in ED on 10/11/13 with parasthesias.  Stated numbness and tingling had progressed to his entire body. Sent home with diagnosis of paresthesias, anxiety.  10/13/2013 to ED with increasing numbness, tingling arms, legs accompanied by pain, chills.  Gradual onset weakness - reported as severe by patient.  Bilateral face affected, unable to swallow.  Patient hospitalized and required intensive care treatment.  On ventilator and ended up with tracheostomy.  Tube feedings and eventual PEG tube.
About a week after the vaccine, I developed raised red welts on my right pectoral and on the right side of my back (on and near the scapula).  Dermatologist said they are shingles.  I have never had shingles before.  They are painful, itchy.
Had COVID-19 in Nov 2020. Vaccinated with Jansen shot in May, but got COVID-19 in August when my husband caught it at work. Our entire household (7 people, 5 vaccinated) caught it. I already had significant post-COVID-19 problems for months in August and was being treated by the local COVID-19 Clinic for dysautonomia, SIRS, vestibular nerve damage and chronic fatigue. This second COVID-19 made all my existing symptoms much worse, plus gave extreme weakness so I couldn't get out of bed for 3 days. I could barely drag myself on the floor to get to the bathroom, just 5 steps from bed. Terrible chills, sweating, excruciating headache. They gave me a Pfizer shot on day 3 of this illness to help me get better immune response. The acute symptoms went on 2 days after that vaccine.
After the first dose I had joint pain and stiffness of movement; after the 2nd dose, I had a moderate fever, headache, and extreme joint pain and difficulty in walking especially going up and down the stairs in our home.  The discomfort in my joints, especially my hips and knees, was so severe I made an appointment with a rheumatologist who ruled out RA and with an x-ray confirmed bursitis in right hip, which was the very first time I ever had bursitis.  Since then my hip pain and stiffness became even more severe and I am now scheduled for a hip replacement in late October. My concern is that the vaccine spiked an inflammatory response with my arthritis and I have been in chronic pain since that second dose...
Constant sneezing since then, missed four days of work, constant congestion to the point of shortness of breath--that was the worst part.  As of now 10/29 still feeling adverse reactions.  Pt. did not seek medical attention for AE. 01/29/2010 - follow up - flu-like symptoms,sneezing, runny nose.
Pt stopped at clinic on 10/25/99, so a nurse could look at his arm. He was referred on to Dr who examined his injection site.
Pain from arm; Pain from wrist, body aches; Bumps on arm; Itching; Pain on injection site; Pain from elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain on injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Medical history reported as rheumatoid arthritis). Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis.   On 08-Mar-2021, the patient 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 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 (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow). At the time of the report, PAIN IN EXTREMITY (Pain from arm), PAIN (Pain from wrist, body aches), VACCINATION SITE MASS (Bumps on arm), PRURITUS (Itching), VACCINATION SITE PAIN (Pain on injection site) and ARTHRALGIA (Pain from elbow) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information included prednisone.
Felt a little hit after shot and was asked to stay 30 minutes cause was a little red and heart rate was a little elevated. The following 2 days had a 103 fever shivers muscle pain and fog in head 4 days later still don't feel 100 percent
fever of 99.4 degrees F; arm soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 99.4 degrees F"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient details with age bracket provided as 20-39 years. No other details are known.  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.
Hives on left lower arm and chest on left side Left arm pains and unable to lay on left side since injection Hematoma under the injection site one month after injection. Headache 6/10
sinus pressure; feel congestion; like allergies; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included LEVOTHYROXINE, LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), SERTRALINE HYDROCHLORIDE (SERTAC), VITAMIN D NOS and VITAMIN B12 NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies) outcome was unknown.            Treatment information was not provided.
Inoculation site red ( 1 1/2 X 3) mildly swollen , very itchy Reaction subsided and has resurfaced this. AM
CHEEKS, chin, mouth, tip of nose, were numb 5 minutes post-vaccination. Pt experienced dizziness, headache, patient went like the throat was closing shut. The headache and dizziness went away. However, patient still experiences tingling on tongue as of the file of this report 06/08/2022 9:48am. Patient has not seen a practitioner as she does not have one.
died after receiving the Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after receiving the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant medications were not reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.  Company comment: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected.   This case was linked to US-MODERNATX, INC.-MOD-2021-012533, US-MODERNATX, INC.-MOD-2021-020196, MOD21-10588, MOD21-086364, MOD21-086368 (Linked Report).; Sender's Comments: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected. US-MODERNATX, INC.-MOD-2021-012533: US-MODERNATX, INC.-MOD-2021-020196: MOD21-10588: MOD21-086364: MOD21-086368:; Reported Cause(s) of Death: Unknown cause of death
Pt stated arm is sore had adverse events and needed to take day off has hard time with movement.
pt recv vax; localized rxn, color, swelling; tx w/ ice at site & dph;
The patient reported itching and rash which did not resolve. He visited the ER today for treatment.
Pulmonary embolisms in both lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Lot number: FJ1620) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Diagnosed prior to vaccination; "Allergies" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent vaccine was administered in a doctor's office or urgent care facility. The following information was reported: PULMONARY EMBOLISM (caused and prolonged hospitalization, medically significant, life threatening) with onset 06Dec2021 15:00, outcome "recovered with sequelae" (Dec2021), described as "Pulmonary embolisms in both lungs". The patient was hospitalized and prolonged hospitalization for pulmonary embolism (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 2 day(s)). The event "pulmonary embolisms in both lungs" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) negative. Therapeutic measures were taken as a result of pulmonary embolism which included blood thinners. Since the vaccination, the patient has been tested for COVID-19 (nasal swab) that was negative on 07Dec2021.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.
Talking about committing suicide; Twitching and vibrating sensation throughout her whole body; Twitching and vibrating sensation throughout her whole body; This is a spontaneous report from a contactable consumer (patient's fiance). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose number unknown, via an unspecified route of administration, administered in the left arm on 13Jul2021 (Batch/Lot Number: FA6780, at the age of 60-years-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included ITP (Immune thrombocytopenic purpura). Concomitant medications were not reported. On 13Jul2021, the patient received the BNT162B2 vaccine. Two days later (on 15Jul2021), she started getting a twitching and vibrating sensation throughout her whole body. She has been to numerous doctors but it won't stop and she was talking about committing suicide now because the twitching and vibrating sensation is constant and it doesn't let up. She describes it as- like sitting on a washing machine that never stops. She was in extremely bad shape now.  The fiance stated that he needed to get her some kind of help because she was ready to commit suicide. It was extremely bad now and the patient needs to get help because this side effect was about killing her. She just can't cope anymore because the twitching and vibrating sensation doesn't stop. She was having an extremely hard time coping. The patient had some blood test and was awaiting the results. The outcome of the events talking about committing suicide and twitching and vibrating sensation was not recovered.  Follow-up (17Aug2021): Follow-up attempts are completed. No further information is expected.
I woke up 12 hours after I got the vaccine with dizziness, nausea, chills, and joint pain. The dizziness got progressively worse (so much so I had to call into work) with the worst dizziness peaked about 18 hours post vaccine. All symptoms resolved within 36 hours post vaccine. The dizziness felt different than my chronic migraine dizziness. I was more disoriented and it was difficult to stand or walk long distances. I had to lay flat most of the day until symptoms resolved.
A report has been received from Health Professional concerning a 26 year old, Female subject, who had been receiving Nasal FLUMIST quadrivalent, 2 doses. FLUMIST quadrivalent started on 17-Sep-2013. The reporter stated that the patient had two full doses of FLUMIST quadrivalent, one in each nostril. The outcome of the event of two full doses of FLUMIST quadrivalent, one in each nostril is unknown. The report was considered to be non-serious.
Fever (up to 101.7), chills, joint pain, metallic taste in mouth.
Left arm hurts and unless I take several ibuprofen I can hardly raise my arm.  I haven?t been to a doctor about it because I keep thinking it will stop hurting. It sometimes wakes me in the middle of the night. I honestly didn?t connect my vaccine to it until today when I went to pick up a prescription from my pharmacy where I got the shot. It just clicked. This feels like a muscle pain. I?m not sure if it?s from the shot but I haven?t done anything to hurt my arm.
left shoulder decreased ROM, pain at injection site. that advanced to increased pain when moving arm. Limited ROM. Pain and limited ROM lasting  longer than 5 months
pt recv vax 23OCT98 & w/in 24hr pt devel hives & was taken to ER;pt dx as having had a reaction to hep b vax;
1 1/2-2 hours after vaccine given-felt SOB, heart racing.  Went home from work.  No medical treatment sought.
FLUMIST was given to child younger than 2 yrs of age. No reaction.
Mom reports infant had immunizations approx 3-4 PM at HD. Infant started getting fussy and had a low grade fever approx 10 AM. Mom reports by 2 PM infant had hives all over her body and difficulty with breathing so mom took infant to ER. Baby had temp of 101 and was vomiting. Baby was at ER 6 hours after 10 PM. Mom states baby got PO Benadryl and oral pedialyte. No IV. Mom states infant has been referred to a pediatric allergist on 3/8/04 to rule out egg allergy per mom. The medical record received on 2/2/04 states decreased appetite.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011188: Original Case: 1809USA010671.
Child immunized 6/13/06 - Received phone call from "Grandmother 6/15 approx 8:00 AM". States noticed redness (diameter tennis ball and swelling diameter golf ball, hot to touch left deltoid area) on 6/14 about 2 PM. States gave Tylenol, child had mild temp. States looks better today (deltoid left) never had difficulty using arm, never complained of discomfort. Advised continue administer Tylenol prn and may also apply topical Benadryl PM, and cool compresses. Advised seek medical attention if notices anything abnormal - drainage, increased swelling, wheezing, inability to use arm.
PT recvd vax on 6AUG92 & on 9SEP92 & devel droopy mouth & the rt side of face was numb; seen in ER dx Bell's Palsy;
day p/vax pt began w/headache, between eyes that spread, feels fretful, didn't sleep well, felt as if heart not beating at times.
A company represntative reported that his 2-months-old niece developed a rash following an injection of Prevnar. No further information was available at the date of this report.
Chills, joint pain, nausea, headache, fever, body aches, fatigue.