chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN LEG; CALF PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced swollen leg. On 19-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen leg and calf pain was not reported. This report was non-serious.
Moderna COVID-19 Vaccine EUA: Soreness at injection site Chills lasting approx. one hour
Developed Myasthenia Gravis (crisis) a few weeks after second vaccine. Hospitalized at from 9/1/21 through 9/14/21. IVIg infusions 9/3/21 through 9/7/21
Fever of 101.8 lasting 24 hours that started 12 hours post injection; Chills lasting as long as fever; headache lasting 48 hours that started as a splitting headache for the first 24 hours, then lightened to a light sore head for the second 24 hours; sensitivity to light in the 24 hours following the fever; fatigue for 48 hours; soreness at injection site starting 2 hours post injection and lasting through the first 72 hours; red welt/rash at injection site starting 48 hours post injection; diarrhea 48 hours post injection; muscle aches starting 12 hours post injection and lasting for 48 hours
On 6/4/18 patients partner presented to pharmacy saying that patient has been experiencing left shoulder pain since the shingles vaccine was given. She stated that the pharmacist must have given the injection too high on 4/23/18. Patient was going to orthopedic dr the next day. On 6/5/18 Dr diagnosed pt with pain in left shoulder; mass of joint of left shoulder; myofacial muscle pain. She stated she did not have significant pain after the shot but had a spasm later that evening that caused pain and move into her neck. She has had persistent pain and spasm since. She has left shoulder pain post shingles vaccine. Symptoms are consistent with myofascial pain syndrome and spasm but she does have a palpable lesion over the left deltoid which could be an abscess. Dr recommended MRI to rule out rotator cuff tear and mass. Dr prescribed ROBAXIN 500 mg 3 times a day as well as over the counter analgesics and heat.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (07Jun2022) positive, notes: positive test result on 07Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse practitioner concerning a 5 year old female who on 11-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck).  No problem was reported.  It was reported that it was not a product confusion but was a medication error.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
It was reported pt post vaccine's developed fever of 105F along with an injection site reaction described as hard, inflamed and swollen. The child also experienced irritability.
Swelling of upper - (R) arm, redness, pruritus, no fever, no tenderness, 11/7/2012 - 11/12/2012, no treatment, resolved.
Patient seen 24 hrs after hep A, PCV13 given in (L) thigh. He had a 5 x 5 area of erythema surrounding needle puncture sites. No flocculence. Mother reported 3 episodes of emesis with 3 hrs that morning. No fever. He did have clear rhinorrhea on exam. Suspected allergic reaction. Recommended BENADRYL. Seen back the next day due to redness expanding to 9 x 9 cm - suspected cellulitis and treated with cephalexin. 07/08/2016. Vomiting/SD. 12 month old baby boy here with his mother/hmm. Had 12mo shots yesterday. Last night decreased appetite and cranky. Woke up around 6am and vomited. He has done it 3 times since. He is refusing food as well. This mother also noticed red area around where he got shots on the left leg. No fever at home. c/o runny nose for the last day. c/o cough a little junky when he first woke up today. Denies: fever, sick contacts. 07/09/2016. Re rash - seen 7/8/16. 12 month 10 day old boy here with his mom. Two days ago got his 1 year shots - got a hep A and a PREVNAR in his left thigh. Usually gets fevers after shots. By the next morning, no fever, but vomited several times and had an area of redness around the vaccination sites. Seen here, assumed reaction, measured at 5 cm diameter, given BENADRYL. Has been using BENADRYL and cool compresses ever since. Vomiting stopped, but rash is still growing. Getting larger ever since being in the office yesterday. Measuring 9 cm across. He isn't itching, it doesn't seem tender.
Patient received a dose of Influenza vaccine (as noted below) at approximately 8:00am.  At approximately 11:00am the patient notes the onset of "itchyness"  at 11:25am Clinic staff was notified. At that time the patient's BP was 156/96 Pulse 76, Resp 18 no distress.  the patient's face was flushed and scalp was red.  Her colleagues reported that her face appeared "puffy".  There was no respiratory distress or involvement.  Patient was monitored for 20 minutes and all symptoms resolved on their own.  Reaction was isolated to head and face.
At 0200, I began having severe chills, body aches, and severe headache. After about 3 hours, it turned to fever (101.8). The only symptoms left now after taking ibuprofen are feeling weak, a little warm, and a headache, and feeling just lousy and tired in general. I had the exact same side effects after receiving my second dose.
Mild pain and redness at the injection site for 3 days Mild headache for 1 day
Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/itching/shortness of breath
mom reports t104.5 beginning 25MAY97 not reduced very much w/APAP;took pt to MD 28MAY97;told was rxn to vax given 21MAY97;temp stil not nl today;pt listless but no other sx present;
After finishing his visit and receiving vaccinations, the individual accompanied by his mother at the reception told his mother that he felt a little dizzy, the mother expressed that it was probably because he had not eaten and suddenly the child began to get dizzy. The individual fainted without answering his mother's questions. Immediately without waiting, the receptionist and the staff called the doctors, and the child was transferred to the exam room. Vital signs were taken, alcohol was used to awaken from fainting, the individual had normal vital signs, and his reaction to fainting was momentary without consequences. The individual was evaluated and sent home in good health by Dr, MD (pediatrician).
p/vax pt awoke w/horrible h/a & nausea;want to throw up in container @ bedside;must have collapsed there;awoke on floor @ 10AM;crawled to phone p/a few mint of confusion & called a friend for help;dry tinny taste in mouth;cold sweat, achy
Itch; redness and swelling around the injection site; redness and swelling around the injection site; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (Lot Number: EW0153) via an unspecified route of administration, administered in right arm (right deltoid) on 10Apr2021 as single dose for covid-19 immunisation. Medical history included asthma, hypertension. Concomitant medications included amlodipine, amlodipine besilate (NORVASC) taken for hypertension, fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma. The patient reported she had the second dose of vaccine on 10Apr2021, on 12Apr2021, when patient woke up, she had redness and swelling around the injection site, on her right arm. It is probably around the size of an apple. On 14Apr2021 (Today), the redness and swelling were about the size of a grapefruit. It itched and it was swollen and it was red. It is like a big circle and its extending from the injection site which was in her deltoid muscle and it is extending over her bicep muscle. The patient stated it had actually gotten a little bit bigger. She would not say it was improved, it was getting a little bit bigger. She had not been to the doctor over this. The patient had not had any kind of treatment for this on her arm. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
i lost strength in my left arm and leg. i couldn?t stand or grip anything. i was experiencing foot drop and getting a blood work up but by the time i did that it was too late. i fell at work and had to go to the ER, i was transferred where i was diagnosed with MS.
Information has been received from a health professional concerning a 72 year old male who on 11/5/01 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 636159/1070K). It was reported that the pt was vaccinated with a 1st dose 5 years ago and had no history of adverse event. On 11/6/01, in the early AM, the pt experienced redness, swelling and pain from his shoulder to past his elbow. He presented to the physician's office for evaluation and it was reported that his arm was swollen, hot and red from his shoulder to past his elbow and into his hand. The pt went to the ER, was treated with prednisone and an antihistamine and was released. The pt was seen at the physician's office since his ER visit and has completely recovered. Upon internal medical review, the pt's experiences were considered "Other Important Medical Events". The reporter expressed a concern with the lot. The reporter indicated that a female pt (WAES 01112307) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Possible breakthrough infection  *1st dose administered at Pharmacy *2nd dose administered at medical facility
chills; sweating; headache/ head hurt; throwing up; throat hurts; eyes and head hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 10:30 (Lot number: ew0172) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bonadoxina, reaction(s): "Known Allergies: Bonadoxina". Vaccination history included: Bnt162b2 (DOSE 1, SNGLE, Lot number: ep1533, Administration time: 11:00, vaccine location: Right arm), administration date: 11Apr2021, when the patient was 39 years old, for COVID-19 Immunization, reaction(s): "delay in my period". The following information was reported: CHILLS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "sweating"; HEADACHE (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "headache/ head hurt"; VOMITING (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throwing up"; OROPHARYNGEAL PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "throat hurts"; EYE PAIN (non-serious) with onset 02May2021 01:00, outcome "not recovered", described as "eyes and head hurt". Therapeutic measures were taken as a result of chills, hyperhidrosis, headache, vomiting, oropharyngeal pain, eye pain.  Additional information: Other medications in two weeks were none. Patient received no other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that first dose was fine, did not have any noticeable side effects but a delay in my period. Second dose got chills, excess sweating and splitting headache first night, felt better about 30 hours after the shot, then 30 hours after that went back to sweating and throwing up. throat hurts, eyes and head hurt. Therapeutic measures were taken as a result of the events included Tylenol. Patient did not have Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Vomiting, fever T-max 100.7. Bilateral leg (thigh) pain. Left thumb intermittently could not raise it.
Symptoms developed on 3/29/21 after exposure to COVID positive person and was tested. Was found to be positive for COVID-19 on 3/29/21. Presented to emergency department on 4/1/21 for worsening symptoms including fever, hypoxia, and cough and was not admitted. Patient presented to ED on 4/5/21 for worsening symptoms and was admitted to the ICU.
Indurated, tender, warm erythematous rash. Treated with heat, ice, NSAIDS and tylenol. Then tx with Keflex empirically
Breakthrough case admission after 3 vaccines ; Moderna 4/16/21 Lot# 030A21A  Moderna 3/25/22 lot# 022J21A;  Moderna 2/2/23 Lot# 010H22A
I had a fever (101) and headache that was intensely painful that lasted about a day.
Low iron found in routine blood tests,  sent to hematologist in Aug.  Put on iron tablets.  First time ever with low iron.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On 15th August 2018, the patient received the 1st dose of Shingrix. On 15th August 2018, less than an hour after receiving Shingrix, the patient experienced pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort. On an unknown date, the outcome of the pain in arm, erythema of extremities, itchy upper limbs and induration were not recovered/not resolved and the outcome of the muscle mass, extremities hot feeling of, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort were recovering/resolving. It was unknown if the reporter considered the pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix injection in her left lateral deltoid and within hours, her left arm was extremely painful. The patient developed a baseball sized lump in her muscle. It was red, hot, painful to the touch, and itchy. Additionally, she got headache, neck ache, and body aches and even her eyeballs hurt. The patient was feverish and had the chills. She felt sick to her stomach and felt as if she was going to have diarrhea. All that lasted through all of the next day and into 17th August 2018. By 17th August 2018 Friday, the patient was feeling better, enough that she could get out of bed. However, her arm was still painful, red, and hard, it felt encapsulated, and itchy. In fact, the hardness and redness had progressed farther down her arm. The patient was unaware of these side effects and was concerned that Shingrix vaccine might cause further illness. The patient would be reporting this to primary care physician and to the proper authorities.
Headache; Stuffy nose; Throat was sore and dry; Throat was sore and dry; Arm was sore; Ran a slight fever, just hitting 100 degrees; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and allergy to nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, day after vaccination, the patient's arm was sore and ran a slight fever, just hitting 100 degrees. The next day on 21Apr2021, the patient had a stuffy nose and throat was sore and dry. On 22Apr2021 (the day after 21Apr2021), the patient's nose was still stuffy, throat was still dry, and had a headache and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm was sore, ran a slight fever, just hitting 100 degrees, stuffy nose, throat was sore and dry and headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt received Zostavax on 7/26/07. On 7/28/07, pt noted pain to left CW under left breast radiating around torso to the back. Approx 10-12 hrs later, he noticed a vesicular rash to area with increased pain consistent with herpes zoster; started on Famvir PO and Bactroban to the open lesions.
Patient developed seizure 30 minutes after receiving injection.  This was witnessed so EMS was called and taken to ED and had another seizure which was witnessed by our staff. I examined patient post ictal.
Injection site redness, swelling, itching, pain and unable to use or touch right arm from the pain. 1 hour after injection, symptoms continue to get worse over the next 6 hours. Heart racing, fevers, joint and muscle pain, sweating, chills, brain fog/confusion, eye pain, body aches, scalp tenderness, nervous,emotional, restlessness, unable to sleep well due to sweating, body pain and short of breath when trying to walk from my bed to the bathroom. In bed for 3 days trying to recover. I took Tylenol and ibuprofen to try and reduce fever and pain. It took 2 days for the fevers to break. My husband had to leave work to help me. I was healthy before the vaccination. Still recovering slowly.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 9:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 75.49.  No concomitant medications were reported.  On 12-Feb-2021, the vial was moved to clinic.  The vial was initially moved to the fridge on 09-Feb-2021 and proposed beyond use date was 10-Mar-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and at 11:00 AM, the temperature recorded was 35 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 12-Feb-2021.  The vials were only punctured right before administration and the dose was drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.     This case was linked to MOD-2022-566976 (Patient Link).
pt returned to clinic 15 mins p/vax w/sxs of coughing, red-watery eyes, rapid resp; pt noted to be wheezing; meds given, sxs appeared resolved w/in 45 mins;
Complete numbness in both hands. Started on Friday Dec 10th at 9:00 P.M. I started getting feeling back on Monday Dec 13th. 50% better on Tuesday Dec 14th. Still not resolved.
Initial information was received on 31 October 2008 from the consumer's parent. A four year old female patient with a latex allergy received FLUZONE intramuscularly in the left deltoid (lot number not reported) on 29 October 2008 at 6:00 pm. On 30 October 2008 at 2:00 am the patient developed a low grade temperature, body was covered in hives which were red, raised, and itchy, The patient's parent gave the BENADRYL. The patient's hands began to swell later that day. The patient was seen by her doctor who prescribed prednisolone and continued with BENADRYL. The patient was scheduled to visit with her allergist. The patient was not recovered at the time of the report. List of Documents held by Sender: None.