chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/29/21 Began experiencing calf muscle tightness with shin splint like pains in left leg.  10/30/21 Left ankle became randomly swollen. No physical injury sustained to cause this. Accompanied with spasms of lightning pain (10 on pain scale) in the ankle and lower shin area in left leg. Random pins and needles pains as well. Visited Urgent Care. Doctor, could not determine cause of swelling. Sited no sprain. Performed blood test for clots and found none. Recommended keeping left leg elevated with periodic icing of swollen ankle. Prescribed Naproxen 500MG. Continued to experiencing frequent lightning pain spasms in left leg throughout the day.  10/31/21 Condition worsened throughout the night. Spasms in left leg, ankle and shin area became more frequent with consistent pain level of 10. Contacted Urgent care and informed them of condition. Recommended to visit Emergency Room to perform ultrasound for blood clots. Was taken by mother to Doctor's Emergency Room. Seen by Physician and Practitioner. Ultrasound was performed and no blood clots were detected. Recommended continue taking Naproxen. Was prescribed Cyclobenzaprine (Flexeril) 5MG tabs and Methylprednisolone 4MG tabs. Discharged from the ER same day. Returned home and continued to experience frequent spasms with lightning pain (10). Pain became traveling and would now be experienced in different parts of left leg. Sometimes ankle, sometimes higher up as close as kneecap.  11/01/21 Spasms persisted but with less frequency. Pain level also reduced from a 10 to 6 on scale. Ankle remained slightly swollen.  11/02/21 Spams very infrequent and pain now localized in lower left shin. Ankle remained slightly swollen.   11/03/21 Spasms and pain had stopped. Ankle remained slightly swollen.  11/04/21 Was able to return to work. (Work days missed 10/30/21 through 11/03/21) Ankle slightly swollen, but no excruciating pain. Had a slight limp.  11/05/21 Slight inflammation in ankle, no pain, walking normal.  11/06/21 Very little inflammation in ankle, no pain, walking normal.
Varicella Information has been received from a physician and a school nurse concerning an 9 year old female who on 19-JUL-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 13-SEP-1996 and 02-JUN-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
A non-serious spontaneous report of administration to a pregnant female was received from a physician concerning an adult female. Neither past medical history nor obstetrical history were reported for this patient. On 08-Nov-2010, patient received FLUMIST. As per the reporter, they inadvertently gave FLUMIST to a pregnant woman. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Patient experienced headache, bilateral weakness & numbness of the upper and lower extremities.  He went to a general practitioner starting in August, but was later referred to a neurologist that diagnosed as Guillian Barre syndrome.  He was admitted to the hospital for IVIG therapy and was discharged after one day to continue therapy at home.  Patient is still undergoing therapy at home, and outcome is yet to be determined.
Pain in Lt arm >15 days after injection.  Denies redness, swelling, irritation, fever.
only received one dose of Shingrix on Sep 15th 2019.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 15th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was looking for some guidance because, the patient was not immunocompromised who only received one dose of Shingrix, till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow-up.
A spontaneous report was received from a consumer concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe pain on the injection site, fever, chills, severe headache.  The patient's medical history was not provided. Concomitant medications reported were Steroid Shot for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) severe pain on the injection site . On 13 Feb 2021, the patient experienced the event(s) fever. chills, severe headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), severe pain on the injection site, fever,chills,severe headache was unknown.
05/24/2003: Saturday 4:00am, woke up with temperature of 101 degrees F.  05/25/2003: Sunday, scratchy throat, some wheezing, and vomited x1.  Continued with temperature through Monday 05/26/2003.  Mom states he is feeling better 05/27/2003.
Side effects: itching all over and was taken to hospital , swelling in arm, and redness on skin.
noticed pea-size lump deep in left lateral arm on 5/24/22. On 6/4/2022 noticed site had grown to approximately 3cm across. Site is warm, skin is slight purplish color without bruising; lump is hard, immobile, and very painful. Saw provider on 6/6/2022, Dx: abscess, was started on Omnicef 300mg. Saw another provider on 6/7/2022 due to increasing pain of site, radiating throughout upper arm; Dx: abscess. Was started on doxycycline 100mg and Tylenol #3. General surgeon consult for I&D of site on 6/8/2022. Ultrasound performed. No abscess evident. Dx: indurated inflammatory response. Voltaren gel suggested.
At time of report, patient has had 4 days of mild rash, which started as 2 small flesh colored papules on left thigh/buttocks. She now has 5 lesions total (1 on her posterior neck, 1 on anterior neck, and 1 on her left lateral abdomen).
This spontaneous report as received from a physician assistant refers to a 14 year old male patient. No pertinent medical history, drug reactions or allergies were reported. On an unknown date in July 2013, the patient was vaccinated with GARDASIL dose 1 (reported as a date therapy started) for vaccination (dose, route, anatomical location, lot number and expiration date were not reported). On 20-AUG-2014, the patient was vaccinated with GARDASIL dose 2, lot # K004204, expiration date 12-JAN-2017, (dose, route and anatomical location were not reported). No concomitant therapies were reported. On 20-AUG-2014, within 20 minutes after administration of the second dose, the patient experienced severe headache and dizziness. The patient sought medical attention by office visit and was given ibuprofen for treatment. The outcome of severe headache and dizziness was reported as recovered on an unspecified date. The outcome of started therapy on July 2013 and second dose of GARDASIL on 20-AUG-2014 was unknown. The relatedness between severe GARDASIL and, headache and dizziness was not reported. Additional information has been requested.
Same day injection site pain. Next day had flu-like sx's, which resolved. This AM developed erythema, induration, pruritus, warmth just below injection site. No acute SOB.
PATIENT SAID THAT SHE HAD REDNESS/SORENESS  IN BOTH ARMS SHORTLY AFTER IMMUNIZATIONS ON 9/17/2020.  SHE CALLED US TODAY (11/3/2020)  AND SAID THAT SHE WAS STILL HAVING SORENESS IN BOTH ARMS, AND IT HAD TURNED FROM SORENESS TO PAIN AND HAD MOVED TO THE BACK OF THE ARM ALSO.  SHE HAD TRIED EVERYTHING I WOULD HAVE RECOMMENDED FOR HER TO TRY.  I RECOMMENDED THAT SHE GIVE HER DR'S OFFICE A CALL, SINCE SHE HAD TRIED EVERYTHING I COULD RECOMMEND FOR HER TO TRY AND IT HAD BEEN 6 WEEKS.
Right thigh induration 2.5" x 2". Treat with Tylenol , cold compress
I had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; NORVASC; METOPROLOL TARTRATE; AMLODIPINE. Past drug history included: Spironolactone for severe muscle cramps in limbs. Vaccination history included: Flu shot, for sore arm/Little worse than a flu shot; Tetanus shot, for sore arm/not as bad as a tetanus shot. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had a sore arm".  Additional information: Patient reported that the side effects of spironolactone, also mentioned being maxed out on Norvasc, switching from metoprolol to "get it down", was recently hospitalized and is on amlodipine. Patient stated that they also prescribed spironolactone, but that one caused, causes me severe muscle cramps in limbs and to mix with, patient stopped taking that one. Patient reported that with the first COVID vaccine patient had a sore arm. Little worse than a flu shot, not as bad as a tetanus shot. And then, the second COVID vaccine, patient was a little achy and had to take a warm bath.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, swelling (L) thigh, started day after administration of vaccine, TYLENOL given. Status improving.
A pediatrician reported post vaccine's pt developed a fever of 103F and swelling at the Prevnar injection site, extending from the thigh down to the knee.
Narrative: Patient received his 2nd dose of j&J on friday, called Monday reporting that since receiving the 2nd shot he had been having diarrhea, bodyaches, and head cold. Patient was advised to use OTC medication for relieve of symptoms and to seek more treatment at facility if needed.
Pt recvd rubella vax approx 29NOV90 & one day following vax, pt exp arthralgia & h/a; On 9JAN91, pt exp maculopapular rash & a flu-like synd consisting of h/a, nausea, fever & chills;
dense mass left breast, July 28 2021 had mammogram, results dense mass in left breast,  Nov 16, 2021 diagnostic mammogram and ultra sound still shows mass  in left breast mass, have been advised that I need a MRI and a biopsy done , feet ankles swell now if I am on feet for more than an hour
Redface,tight chest, red trunk, hard to breath, crying began about 20 minutes after leaaving office. Benadryl given by school nurse then child returned to doctors. Given epinephrine and albuterol
My baby has had diarrhea ever since she was administered the rotateq  vaccine.  I have already taken her in to her doctor six times and to a infection specialist two times because her diarrhea does not stop 6 to 7 bowel movements a day, she was crankier because she felt uncomfortable from her stomach. She has already been change from her formula three times. She still has not recovered and its been over a month.
cold; Since she is on Ibrance then the accine is less effective; This spontaneous case was reported by a consumer and describes the occurrence of INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective) and NASOPHARYNGITIS (cold) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included PALBOCICLIB (IBRANCE) for Cancer.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective). On an unknown date, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, INHIBITORY DRUG INTERACTION (Since she is on Ibrance then the accine is less effective) and NASOPHARYNGITIS (cold) outcome was unknown.            No concomitant medications were reported.  The patient reported that the nurse practitioner told her since she is on Ibrance (palbociclibo) the vaccine is less effective. The patient wanted to know if it is true. Patient stated the doctor did not think that the cold and the vaccine are related. She also stated that her grandson got a cold from pre-school. There is a product complaint on Ibrance.  No treatment information was reported,  Action taken with mRNA-1273 in response to the event was not applicable.   Company Comment: Very limited information regarding these events has been provided at this time. Further information is required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is required.
JOINT PAIN ON THE SHOULDER (WHERE TOOK VACCINE); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced joint pain on the shoulder (where took vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain on the shoulder (where took vaccine) was not reported. This report was non-serious.
Daughter reported that the family noticed a lump in her arm after receiving the vaccine 6/18/2021. The lump has since subsided, but about three weeks after the second dose a large dark purple and red mark presented itself and still remains. The area is about 4-5 inches in diameter and is not uncomfortable, itchy, or painful.
14 well separated thin blistered lesions on deltoid area, no erythema - 5-10 mm.
Pain and swelling at site started a few hours after the shot was administered. It was quite bad about 11 hours later, and I could not lie on that side. The day after the vaccination, I have a headache, slight nausea, and muscle aches.
Chills; trying that he won't throw up; This is a spontaneous report from a contactable consumer. A male patient (reporter's Dad) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: Unknown) on 25Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced chills and he is trying that he won't throw up in Jan2021. Patient got the first COVID shot yesterday (Clarified as 25Jan2021) about 2:30 and about 26 hours later, he has no symptoms or nothing and just an hour ago it's been about 26 hours he has chills. Reporter asked if that is common. Reporter think he is trying that he won't throw up. Reporter have been thinking if he had the chills just a few hours after he got the shot. It's been about 26 hours. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient presented to the ED and was subsequently hospitalized for atrial fibrillation with RVR within 6 weeks of receiving covid vaccination.
Information has been received from an office nurse manager concerning a female patient "in her twenties" who was vaccinated with a third dose of GARDASIL. On 05-OCT-2007 the patient experienced vomiting. Treatment was unspecified. At the time of the report the patient's outcome was unknown. The office manager reported that the patient felt that the patient's vomiting was related to GARDASIL.
Patient became lightheaded minutes post vaccine. No medical intervention needed. Reassured and offered water.
Information has been received from a 77 year old male consumer who in winter 2006 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included simvastatin (manufacturer unspecified), lisinopril and SYNTHROID.  On approximately 03-AUG-2007 "about 10 days ago" the patient experienced a breakthrough shingles.  The patient had blisters on lips which were swollen.  It hurts and was red under his lips at the jaw and around left ear.  He went to a dermatologist who said it was from the trigeminal nerves and diagnosed the shingles on 13-Aug-2007.  Dermatologist prescribed VALTREX and a cream (unspecified).  The patient's shingles persisted.  Additional information has been requested.
I made mistake and took Shingrix series 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix and the 4th dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient mistakenly took Shingrix series 2 times, which led to extra dose administered. The reporter asked if he/she was ok.
Swollen & sore at injection site within 24 hours of injection and still the same 4 days later.  Took Tylenol two times, 4 hours apart, day after injection.  No other treatment.
The patient stated that she had a fever with a temperature at 103 degrees F the day after getting the vaccines. The fever went away that night.
9 pm- chills, cold, body aches, jt pain weak. Denies Temperature no treatment. Symptoms through the night. 9AM - aches, weak improved.
Shot 1 (3/21/2021) Soreness and severe swelling at the site of facial fillers (chin, lips, cheeks) that started about 24 hours after the first shot and lasted another 24 hours  Shot 2 (4/21/2021) Nurse who did facial injection recommended taking Prilosec and Zyrtec to prevent swelling. That worked but the day after the second shot I developed a red rash that extended the length of my bicep starting from the injection location. Is going away but still slightly visible on 4/26/2021.
Patient received hepatitis B recombinant vaccine 20 mcg IM to right deltoid on 8/14/08 at an acute care facility.  Patient was admitted to our outpatient substance abuse treatment rogram and had LFTs on 8/26/08 as follows:  AST 1516, ALT 390, alk phos 59 and total bilirubin 0.8.  Only medication change in time period was administration of the vaccine. LFTs normal prior to the vaccination.
Coughing; little bit of aches in the body; feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm on 27Jan2021 14:00 as single dose (at the age of 75-years-old) for COVID-19 immunization. Medical history included asthma, high blood pressure, cholesterol, allergies and environmental allergies (patient is allergic to everything outside. She is allergic to the environment. She is not allergic to drugs). Concomitant medications included pravastatin, levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR) taken daily for allergies, fenofibrate, lisinopril taken for blood pressure, albuterol [salbutamol] and acetylsalicylic acid (BREOPRIN) both taken for asthma; for all drugs start and stop date were not reported. The patient previously took B12 shot (cyanocobalamin) in the beginning of Jan2021. She went to her doctor's office and they give it. She doesn't have NDC, lot, and expiry to provide. Dose for B12 shot is unknown. No adverse event following prior vaccinations. No additional vaccines administered on same date of the pfizer suspect. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No previous medications before vaccination. Patient also reported she takes regular medications daily. She clarified that she didn't take any of her medications prior to getting the COVID vaccine. Patient was feeling fine and then it hit her on 03Feb2021 at 16:00, the patient experienced cough and little bit of aches in the body and started feeling bad. Patient reported aches are almost gone and just started coughing last night (On 03Feb2021). It was reported that yesterday (on 03Feb2021) patient went out and she started feeling bad and normally would think it was her asthma, but she wanted to make sure that she'll still get COVID after getting the shot. No emergency room and physician office visit required for adverse event. No investigation assessment. Therapeutic measures were taken as a result of cough with cough medication. The outcome of event for coughing and general body pain was recovering and for other event it was unknown.  Follow-up attempts are completed. No further information is expected.
Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates.  COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice.
Patient received ROTATEQ on 1-27-09, developed intussusception on 1-28-09, required surgical repair 1-28-09. 2/9/2009 MR received for DOS 1/28-31/2009 with D/C DX:  Intussusception. Pt presented with bloody, mucus stools, abdominal pain, irritability, nausea, decreased PO and vomiting. PE (+) RLQ tenderness. IS unable to be reduced using Barium Enema so pt taken to OR for surgery-open reduction with appy.  Uncomplicated post-op course.
Pt developed a dark red, 2 cm diameter area surrounding injection site with 7 cm diameter area of lighter redness, warm to touch, on left leg. Dark red 4 cm diameter area surrounding injection site with 15 cm area of lighter redness surrounding injection site on right leg, also warm to touch.
Received Tdap on 09/06/12 and 3 days later started with itching & developed extensive swelling, redness, induration & warm to touch it entire upper arm extending from left deltoid to above the elbow. Currently being treated for cellulitis of left upper arm with AUGMENTIN generic.
SORENESS ON ARM WHERE SHOT WAS GIVEN FOR (3) THREE DAYS - THEN IT WAS OK. (3) DAYS LATER ARM SORE AGAIN - ITCHING  REDDISH AND WARM - IT'S GETTING BETTER