chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5 yr old male subject who was vaccinated with adsorbed diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. Concomitant vaccination included inactivated poliomyelitis virus vaccine (IPOL), left arm given on 02May05, and measles, mumps and rubella virus vaccine (MMRII), left arm given on 02May05. On 02May05 the subject received 5th dose of Infanrix (lotAC14A010BA), .5ml, to the right arm. On 03May05, 1 day after vaccination with Infanrix, the subject experienced cellulitis at the site of Infanrix injection and presented to the physician's office. The physician felt the event jeopardized the subject and required medical intervention (not specified at the time of reporting) (OMIC). The nurse stated the clinic...feels there is a problem with this lot number of Infanrix. On 07May05, the event resolved. The healthcare professional considered the event was related to vaccination with Infanrix.
Patient developed severe pain in left arm where vaccine administered with swelling. Complained of problems sleeping, choked x 1 and (L) leg felt "weird". Started the day of vaccine. Improving at this time.
Cyst, open wound spots every on body, bones and joint hurt, hand an feet hurt, swelling. Numbing. Tingling, severe headaches, sinus issues, being testes for possible blood disorder/cancer, calcification in spine, bleeding from vaginal over 2 months, active infection in body, each day a new symptom shows up, swallowing issues. Lost voice,  loss of hearing, being tested for Rhamatoid arthritis and lupus, see mutiple specialist for all this.  Have not worked since 11/2021
No adverse event; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Nurse referring to a patient of an unknown age and gender. Information on patient's medical history, concurrent condition, drug allergies/reactions and concomitant medications were not reported. On 18-FEB-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose: 1 dose, strength, frequency, route not reported) lot # 1660112, expiry date: 18-OCT-2020 for prophylaxis. The vaccine was stored at a temperature of below 2 degree Celsius(1.28 degree Celsius) for 2 hours and 30 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a family nurse practitioner and refers to a currently 20-year-old female patient. The patient medical history included fetal anomaly and one previous pregnancy with elective termination. The patient had no concurrent medical condition.  On 15-APR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot no. R024264 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 29-OCT-2019 (exact dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The patient's last menstruation period (LMP) was on 09-APR-2019, the estimated date of conception was 23-APR-2019 and the estimated due date (EDD) was reported as 14-JAN-2020. Gestation period at exposure could not be calculated as the vaccine was administered before the estimated date of conception.  The pregnancy outcome was outcome pending.; Sender's Comments:  US-009507513-1905USA008649: US-009507513-1905USA008648:
Shortly after vaccination while pt was waiting for 15 in waiting area, she said she didn't feel well and started to pass out. Staff was able to catch her and bring her to sit on floor. She was flushed and sweating and felt out of it but never passed out completely. She asked for water and vomited multiple times after that. She requested EMS be called and they evaluated pt with normal vital signs. Pt then felt better and had husband come and take her home. Just lingering tingling in arms she stated at that time, but was otherwise feeling mostly back to baseline.
Fever to 103 approximately 9 hrs after receipt of vaccine resulting in generalized T-C seizure lasting approximately 10 min. Taken to ER and admitted overnight for obsv.
It was similar to the first two shots. That night I went home and the pain became worse. I put ice packs on it and became very fatigued. It continued for two days to the point where I couldn't get out of bed. After that the pain started moving down my shoulder to my arm. I treated it with ice packs. It was hard to lay down and I wasn't able to sleep. None the less it was getting worse so I contacted the doctor a week later. I also have a doctor I see for my Peripheral Neuropathy and the doctor said it should eventually go away. I basically treated it with Tylenol and ice packs. It went through Thanksgiving, Christmas and New Years. Finally at the end of December I saw my primary care physician for my annual check up. She took some x-rays and so forth and thought I should try some physical therapy. She thought it could be bursitis but I've had bursitis before and its way worse. The fatigue is the main component of it. She did give me Celebrex. The Celebrex helped for a bit but it was extremely hard on my stomach since I have Gerd.
Felt crappy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt crappy) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt crappy). At the time of the report, ILLNESS (Felt crappy) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
Received "23 pneumonia vaccine" with an underlying autoimmune condition resulted in frozen shoulder; This spontaneous report was received from a health care professional via Pfizer regarding a female patient of unknown age. The patient's current conditions included an autoimmune disorder. Her medical history included facial paralysis. The patient's drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration, anatomical injection site, lot number, and expiration date were not reported) as prophylaxis. At the vaccination time, the patient had an underlying autoimmune condition resulted in frozen shoulder (periarthritis).  The outcome of the event was unknown.  The causal relationship between periarthritis and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided
Within 6 hours of injection had headaches that lasted 36 hours. Day two redness, heat  and swelling hands-width below injection site.  Day three same symptoms as day two but spread to length of arm below injection site to within hands-width of bend in elbow.  Day four redness, swelling, heat, itching, discomfort to elbow and wrapping around inside of bicep. Day five same as Day four. Day six the redness, heat, itch, and swelling receding. Day 7 further diminished symptoms. Day 8 further diminishment. Symptoms almost gone.
5 minutes after receiving the vaccination patient felt very warm. She stated she did not feel well. About 2 minutes later she stated her lips and tongue felt numb.
TENDER TO TOUCH; MILD SORENESS IN INJECTED ARM; BOTH LEG PAIN; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included stromal tumor, right thyroid removed, and total knee replacement, and concurrent conditions included brain aneurysm, reflux thickening of uterine wall, asthma, seasonal allergies, non alcohol user, non smoker, and brain tumor, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced both leg pain. On 05-MAR-2021, the subject experienced mild soreness in injected arm. On APR-2021, the subject experienced tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both leg pain on 2021, had not recovered from mild soreness in injected arm, and the outcome of tender to touch was not reported. This report was non-serious.
Muscle twitching that started in the left foot, then spread to calf, leg, arm, and trunk, as well as face and hands. Sometimes accompanied by vibrating sensations, pins & needles. The twitching is constant, never stops, and interferes with sleep. Symptoms increased in degree and severity after 2nd vaccination.
blood vessel bleeding in my nose; Slight headache; A spontaneous report was received from a 70 year-old, male patient, who received Moderna's COVID-19 vaccine and experienced slight headache and blood vessel bleeding in my nose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced a slight headache on his way home and continued to have symptoms of the headache since, occasionally. On 29 Dec 2020, the patient woke up and had a blood vessel bleeding in his nose. The patient's nose bleed had stopped at the time of reporting. Treatment for the events included two acetylsalicyclic acid, and one paracetamol.  Action taken with mRNA-1273 in response to the event was unknown.   The event headache was considered not resolved.  The event blood vessel bleeding in my nose was considered resolved on 29 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Multiple erythema pinpoint papules on the trunk. 3x3 induration with erythema papule in the center located in the Rt upper thigh.
6-20-13 call from pt. reports on 6-18-13 awoke with pain in (L) elbow and wrist. Used Ibuprofen for comfort 6-19-13 pain continued (L) elbow, wrist, index finger at evening time (L) knee also severe pain. No redness, swelling or change in range of motion. Used ALEVE 2 tabs 6-20-13 AM - pain persistent. 6-21-13 - 6-22-13 Bil knee pain and swelling resolved 6-23-13.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted shortly after vaccine was administered. Was feeling better after 15 minutes, gave him some water and coke to drink.
NUMBNESS. FATIGUE Slight fever yesterday from 2ND DOSE  vaccine 02/16/2021
pt recvd vax & described breaking out in hives immed after vax; tx w/ DPH;
Patient report that she has pin and needles feeling in her hands and feet and a buzzing sensation....
Hotness at injection site; Redness at injection site; Pain at injection site; This spontaneous case was received on 25-Sep-2020 from pharmacist via agency (reference number: SEQW20-02361) and concerned a 57-year-old, female patient.  The patient's concurrent conditions included type 2 diabetes (T2D) and hypertension. The patient's concomitant medications included metformin, omeprazole and verapamil all used for an unreported indication.  On 23-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, dose: 0.5 ml, anatomical location: some inches above the elbow as reported) for flu prevention. The batch number reported was 276575, expiry date: 30-Jun-2021. The used needle was 1 inch 25 gauge (g).   On 24-Sep-2020, one day after receiving Flucelvax QIV, the patient was having redness, hotness and pain at injection site. Only ice was used as a treatment, as reported.  At the time of initial reporting on 25-Sep-2020, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 57-year-old, female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed vaccination site pain, vaccination site erythema and vaccination site warmth. Only ice was used as a treatment, as reported. Causality is assessed as possibly related. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A 57-year-old, female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed vaccination site pain, vaccination site erythema and vaccination site warmth. Only ice was used as a treatment, as reported. Causality is assessed as possibly related. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.
Low grade fever, aches, chills, rapid heart beat of 120/min beginning the next day, about 8 a.m. (15 hours later). Took Ibuprofen 1 p.m. and sx gone at 10 p.m., 14 hours after onset. Mom did take child to ER early evening.
Deep muscle pain under site of injection R arm.T his pain is an ache and very bad, a 7 on a one to 10 scale. Pain is worse over injection site but extends across back over scapula to spine. Back of hand tingles and tip of right thumb is numb. No impairment of muscle function. No swelling. Pain started 11-24-05 (+16days). Has continued 3 days now,not relieved by Excedrin Migraine,some relief from Acetominaphen + codeine #3. No fever.Arm feels "heavy".Quite unbearble w/o pain med. I have tried to contact clinic but unavail due to holiday. There is nothing to "show" so haven't gone to ER or DR.yet. May go if continues. Some relief from heating pad. Really hurts a lot. Information from Follow-up report states: Recv'd IM Hep B on 11/08/05 in right arm. On 11/23/05 (16 days after inj) inject site became extremely painful ( 7 on 1-10 scale). Also right thumb became numb. Pain continued at that level for approx. 2 weeks. Currenty is 4 on 1-10 scale and right thumb still numb, occasionally right arm and thumb tingles. Relief from 3 aspirin or extra streneth Tylenol, which I must take everyday, several times.
pt recv vax 3FEB97 & 13FEB97 pt devel small red spots around the inj site;the spots lasted for 4 days & then disappeared;No further details were provided;
Caller states that her husband developed itching, red rash on front of upper arm, near injection site, warm to touch and slight swelling. Aprox 2 inch circle, not getting any worse or better. Denies fever or any other symptoms. Has tried topical ointment with no relief. Advised tylenol or ibuprofen, cool compresses and/or topical benadryl  Follow up call by Patient feeling much better, swelling and redness to the injection site resolved. Cold compress and benadryl ointment administered to alleviate symptoms.
Moderna COVID-19 Vaccine EUA Vomiting Bilateral hip pain Numbness in neck Fever - 101.2 Headache - like it?s being squeezed in a vice Upper teeth hurt Cheeks hurt Can?t move my head without vomiting
Right deltoid inflamed red and itchy. Occurred approximately 2 days after injection. After injection fever occurred approximately 5 hrs later. Also headache.
woke up feeling very groggy, double vision, woozy, weak. Tried to fill coffee pot but no strength, went to sit at kitchen table. Tried to stand and collapsed on floor. Husband called 911. Took blood pressure, glucose reading and EKG. All were OK. Told me to advise my doctor. Went to him next day and he said based on symptoms it sounded like severe hydration. He was not sure if it was attributed to the vaccine.
Information has been received from a physician and a healthcare worker refers to a patient of unknown age and gender. On 10-FEB-2015 the patient was vaccinated with an improperly stored dose of M-M-R II, lot # K002527, expiration date: 18-FEB-2016, dosage and route unspecified. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
celullitis at the injection site; the site of injection was big / size of a baseball, it was elevated; the site of injection was uncomfortable; injection site was red; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In October 2012, the patient received Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix around October 2012 and noticed at the site of injection was uncomfortable and red.  She called her physician and her physician told her keep an eye on the event. The next day she saw her physician and the site of injection was big. It was the size of a baseball, it was elevated. The patient physician diagnosed her with cellulitis at the injection site.  The patient had antibiotics prescribed.  The physician drew with a pen around the reaction and told her to go immediately to the hospital if it grew but it did not. The reporter consented to follow up. Emergency room visit required. The patient did not had further information on the physician at the time of the call but she welcomed safety to call her back and she might be able to pull additional information from her files or provide more information on her physician's contact information. For tolernace of Flu vaccine, refer case US2020AMR087869.
Mother states that patient came here from school yesterday and complained of an almond-sized lump with tenderness to touch at injection site.  Patient had been scratching 2 mosquito bites near site when he noticed the sensitivity of the site.  No fever, no erythema reported.
Approximately 12 hours after vaccination; an onset of myoclonus seizures began.  During the first hour, as many as 16.  This continued from 10/15/08 through 10/19/08 when primary care on call contacted.  When arrived at his office on 10/20/08, sent to hospital where I remained for the next 3 days.  I still continue to be treated for the siezures with medication.  They have lesssened in severity and frequency but have not stopped as of yet.2/6/09-records received-presented on 10/20/08 with C/O twitching sensation in neck began 5 days ago and then 2 days ago developed episode of soliatry twitch and sudden jerking movements while walking and became disoriented and confused. MD informed patient to discontinue Lyrica, however twitiching and confusion returned. Impression:seizure like activity. Twitching. 2/13/09-records receive for DOS 10/20-10/21/08-neurology consult:anxious and high strung appearing and exam WNL. Impression, abnormal involuntary movements, perhaps myoclonic jerks versus ballistic movements verus seizures.  Follow-up: Still continue to have myoclonic jerks. Still under neurologist care and haven't been able to work since June '09 when doctors had exhausted all medication trials; none of which have been successful in controlling the symptoms.
No Fever, but she experienced chills, nausea, lightheadedness, was disoriented (on Saturday), and had throbbing joint pain (hip, elbows).