chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-AUG-2015, the patient was vaccinated with ZOSTAVAX (route, dose, lot # and expiration date were unknown) for prophylaxis; that was reconsitituted with sterile diluient (dose, lot # and expiration date were unknown). Later, on 15-JUN-2017, the patient was again vaccinated with ZOSTAVAX lot # M034766, expiration date 26-OCT-2017 (route and dose were not reported) for prophylaxis; that was reconsitituted with sterile diluient, lot # M024786, expiration date 19-FEB-2019 (dose was not reported). Information regarding concomitant medications was not reported. No adverse effects were reported. Additional information has been requested.
Delayed 2 two days post vaccination -upper left arm-at site of injection. Became red, warm, swollen and very tender and painful-2 weeks later-still pink and slightly swollen.
7PM pt became listless & had t103 & lt upper arm swollen (3 1/2" long x 2 1/2" wide), red & hot;mom gave pt APAP & Motrin; sx remained the same on Sunday AM;mom called MD & put cold wet packs on arm;Monday AM to MD arm still red & swollen;
very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: SHINGRIX (Dose 1), SHINGRIX (Dose 2) and SHINGRIX (Dose 2). Past adverse reactions to the above products included Pain in arm with SHINGRIX and SHINGRIX; and Sickness with SHINGRIX. Concomitant products included ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Thyroid disorder.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-370088, MOD-2021-404925 (Patient Link).
Initial report was received from a healthcare professional, who was also the patient, on 11 February 2013. The reporter in this case is the same reporter as case number 2013-02622. A female patient (age and date of birth not reported) received an intramuscular injection of FLUZONE High-Dose, lot number U4492BA, in December 2012 (also reported as "12/12") (site not reported). An unspecified amount of time later, the patient got the flu while traveling overseas. Past medical history was unknown. Outcome was reported as recovered. Documents held by sender: None.
pt recv vax; therapy included metoclopramide;on 11jun96 pt devel chicken pox w/ greater than 200 lesions;
Patient was initially administered only half dose (0.25 milliliters) of the recommended (0.5 milliliters) moderna bivalent dose. Approximately 7 hours later, the additional 0.25milliliters was administered. No adverse reactions reported.
rash.  ? if started ~6/8/09.  came into office to be seen on 6/15/09 with edematous papules, esp on forearms and thighs.  macular lesions of lower back and buttocks.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958249, 20210958321, 20210958892, 20210958366, 20210958993, 20210958405, 20210958502 and 20210933076. This case, from the Others is linked to 20210959351 and 20210958518.
I found it atypical the way this young man pinched my shoulder, how I never felt any pinch, and how quickly it was over.  I didn't feel any of the usual uncomfortable feelings associated with getting a vaccine.  I had the first Covid vaccine on 2/3/21, the shingles series 7/25/20 and 9/25/20, and the flu vaccine on 9/25/20.  Each of these vaccinations were slightly uncomfortable, swelled almost immediately and were sore for at least a day.  Today I am writing this at 6:30pm, and it doesn't feel like I've had a vaccine, despite being told by my vaccinator that I may feel flu like symptoms after this 2nd vaccine.  I am wondering if it was administered at all, or if it was subcutaneous, or vaccine was accidentally sprayed out before going into my arm??? Something is not right.
I had a mild headache, and later in the day developed some chills and low grade fever. My arm was quite sore
Moderate localized injection site muscle pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 17:45 (Lot number: FC3181) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Aug2021 06:00, outcome "recovering", described as "Moderate localized injection site muscle pain.". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: patient has not taken any other vaccine within four weeks. Treatment received with Acetaminophen w/caffeine.  Patient was not tested with covid-19 prior to vaccination and not been tested since the vaccination. Other medical history: I will provide if contacted. List too long for this form.  No follow-up attempts are possible. No further information is expected.
I started to notice mid February 2021 that I was having joint tenderness in  both hips and knees with some lower back aches.  This is not preventing me from work or activities of daily living but significant enough to report especially the bilateral hip (joint) tenderness which I have never had.  I walk 2.5 miles 3 times a week (my routine) and for the first time am noting the discomfort.
pt recv vax;pt was twitching in rt leg where vax given;T 103;was advised to see MD;mom states pt did move when vax given & told leg would be sore;states MD tx w/ augmentin for cellulitis;24jul pt better,leg healing nicely;
This spontaneous report was received from a physician via a company representative via Poison & Drng Center (RMPDC) (US17-009665) referring to a 6 month and 5 days old patient of unknown gender. The patient's past medical history, concomitant medications, and past drug history were unknown. On 15-OCT-2016 the patient was vaccinated with the first dose of ROTATEQ (lot# M018957, one time dose) orally for prevention of rotavirus gastroenteritis. On 06-DEC-2016 the patient was vaccinated with the second dose of ROTATEQ (lot# M031805, one time dose) orally for prevention of rotavirus gastroenteritis. On 14-FEB-2017, the patient presented to the pediatrician office with a rash on the bottom, severe diarrhea, and bloody stools. On 14-FEB-2017 the Adena/ Rota Antigen Rapid Test was performed in the pediatrician office and the results were negative. The patient continued to worsen. On 15-FEB-2017 the patient was admitted to hospital. On an unknown date, while admitted to the hospital, the patient tested positive for the rotavirus and received Total Parenteral Nutrition (TPN) via a nasogastric (NG) tube trickle feed. The patient improved to formula feedings on an unknown date and on 27-FEB-2017 the patient was released from the hospital. As of 08-MAR-2017 the physician recommends against giving the patient the third dose of ROTATEQ. On an unknown date, patient's rash, severe diarrhea and bloody stools had recovered but the patient was still on a modified diet. The causality between the event and ROTATEQ was not reported. Upon internal review, bloody stools was considered as medically significant event. Additional information has been requested.
Patient had shot around 2:00 pm then presented with a rash on arm around 6:00 pm the same day.
Cough, sneezing, sniffling, body aches, drainage, congestion, throat pain, ear pain, LOOSE bowels/diarrhea(continued for 3 weeks; controlled by BRAT diet, Imodium, Pepto-Bismol), rhinorrhea, nausea, myalgias, meddle ear effusion both ears, Prescribed Molnupiravir, Isolated 10 days (no work for 15 days), mostly resolved by 12/12/2022
Pt recv vax on 12/15/98; on 12/18/98 pt exp numb LA  &neck, fever blister on lip
This is my second dose. Received vaccine 5/7/2021 about 4:15pm. Starting 5/10/2021. Itching at the site, swelling in face, and swelling in lips. Treating with Benadryl Gel tablets.
COVID vaccine breakthrough case. Moderna 3/4/21 040A21A, Moderna 4/1/21 026B21A and booster Moderna 11/28/21 012H21B
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 24-JAN-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Developed severe sacrum, pelvic, and hip flexor pain. Muscle spasms across front of pelvic girdle. Could not move without assistance. Weakness through lower back and sides, gait disturbance. ER physician administered the following via IV: Decadron Dilaudid Toradol Robaxin lactated ringers lidocaine patch Prescribed course of methylPREDNISolone
This spontaneous report was received from a registered pharmacist and refers to an unknown age and gender patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-SEP-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot number M032635, expiration date 02-MAY-2018 (anatomical location, dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported.
Swelling, itching and discomfort at site, weakness in arm and body, headache.
Severe pain in the left arm where vaccine was taken  Swelling at the vaccine site  Redness at the vaccine site
Exactly one week later I suddenly broke out in hives all over my body. They were controlled by Benadryl and faded over about 48 hrs. Following the hives, a rash formed over my whole body in the form of small patches that were bumpy and red. One month later the rash persists and perhaps worsens. It is not itchy, but slightly painful when scratched.
A few weeks after my daughter was given the first part of the HPV shot she began having involuntary movements and sounds. I called her doctor who insisted that it was not the shot. She referred us to a neurologist. Over the next week or two, the movement got worse and worse. They are not as bad now, however, they still occur daily.
pt recv vax 10NOV97 & that same day pt exp fever to 103, pain & a site rxn on the thigh described as red & swollen;pt was treated w/APAP & cold compresses;
This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical histories and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of VAQTA (lot # K005958, expiry date 09-FEB-2017; lot # L009445, expiry date 01-JUN-2017) through unknown route. Concomitant medications were not reported. No adverse events were reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker regarding unspecified patients of unknown demographics. There was no information regarding concurrent conditions and historical medication. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX which was exposed to 12F for 40 minutes. No concomitant medication was reported. No product quality complaint was involved. No adverse effect was reported. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm 3 days.  Fatigue - 2 weeks. Headache - few days.
This spontaneous case reported by a consumer, describes the occurrence of chest discomfort (chest tightness), aphonia (losing my voice), headache and pyrexia (fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced chest discomfort (chest tightness), aphonia (losing my voice), headache and pyrexia (fever). At the time of the report, chest discomfort (chest tightness), aphonia (losing my voice), headache and pyrexia (fever) outcome: unknown. Concomitant medication and treatment information not provided.
Fatigue started 60 minutes after vaccine - lasted 48 hours; Dizziness started 30 minutes after vaccine - lasted 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and allergy to sulfa (sulfonamide allergy) and cherries (fruit allergy). 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 vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), cyanocobalamin (B 12), probiotics (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 06Apr2021 at 10:30, 30 minutes after the vaccination, the patient experienced dizziness that lasted for 36 hours. On 06Apr2021 at 11:00, 60 minutes after the vaccination, the patient experienced fatigue that lasted 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness was recovered on 07Apr2021 at 22:30; while that of the event fatigue was recovered on 08Apr2021 at 11:00.   No follow-up attempts are needed. No further information is expected.
Pain in axilla, breast, & arm starting about 24 hr after vaccination & lasting 3 days. Also red streak on arm lasting a few days.
Extreme numbness and tingling in full body, including legs, arms, neck, and face. Started a few hours after getting the vaccine. Was consistent for 3-4 days follow. I now have numbness in waves. Sometimes now it is just parts of my body going numb. Not always my full body. But I have yet to go a day, or even a few hours without experiencing numbness or tingling.
Shot administered on Monday 8/11/2008 my son then had hives rash over his body by Thursday 8/14/08.
GENERALIZED MALAIZE, CONFUSION, POSSIBLE SYNCOPAL EPISODE, ELEVATED TROPONIN, RHABDOMYLOSIS, COVID POSITIVE
UPON WALKING OUT OF THE FRONT DOOR OF THE STORE, THE PATIENT FAINTED.  HER DAD SAYS THAT HE CAUGHT HER.   THE DAD AND PATIENT SAYS THAT SHE DID NOT HIT HER HEAD.  PATIENT CAME BACK TO PHARMACY LOBBY AND SAT FOR A WHILE.  PATIENT RESPONDED NO TO QUESTIONS OF FEELING LIGHT HEADED, NAUSEA, COLD SKIN SWEATING,  IRREGULAR HEART BEAT, CHEST PAIN, BLURRED VISION, CONFUSION, LIMB WEAKNESS AND CONVULSIONS.  A POLICE OFFICER RESPONDED TO A CALL THAT SOMEONE PLACED UPON SEEING HER FALL OUTSIDE.  THE POLICE OFFICER ASKED THE DAD IF SHE WOULD LIKED TO BE CHECKED OUT BY THE EMT'S ARRIVING.  DAD SAID YES.
Patient fainted after getting shot.  She remained seated and did not fall.  When patient woke up, I monitored her for 30 minutes and took several blood pressures.
PATIENT CALLED PHARMACY ON 7/17/21 AND TOLD US SHE GOT THE VACCINE ON 7/7/21. SHE HAD NO SIDE EFFECTS, UNTIL MONDAY 7/12/21 WHEN SHE WENT TO URGENT CARE AND DIANGOSED WITH SHINGLES. SHE SAID THEY WERE PRESENT ON HER HIP.
Nausea; Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations were not reported. This patient experienced fever and nausea on unspecified date in Jan2021. The outcome of events was not provided.   Information on the Lot/batch number has been requested.
She developed a fever around 10:46pm of 101.5 and a very fast heart rate over 137bpm. Shortness of breath and immediate chest pains..
currently has shingles / Suspected vaccination failure; shingles; first Shingrix dose was 4 to 6 weeks prior to second dose; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to receiving Shingrix).   On 09-AUG-2019, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, the patient received the 1st dose of Shingrix. On 09-AUG-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first Shingrix dose was 4 to 6 weeks prior to second dose). On an unknown date, the patient experienced vaccination failure (Verbatim: currently has shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with famciclovir (Famvir). The outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 09-AUG-2023 The reporter was a patient and reported that he received 2 doses of Shingrix and currently had shingles and this was the first episode since vaccination. The reporter reported that his second dose was 4 to 6 weeks prior to that 1st dose but it was certain as he did not have his paperwork with him. The reporter reported that he was took an 8-day course of Famvir and shingles outbreak was improving. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test was unknown at a time of reporting. The patient received the 2nd dose earlier than recommended interval, which led to lengthening of vaccination schedule.
12 hours after my vaccine, I woke up with chills and night sweats. I had a fever of 101° and felt nauseous. My whole body aches and I have had a headache since waking up with the fever. My fever broke after taking acetaminophen and drinking water. Arm continues to feel very sore and my muscles and joints ache in my legs and back.
Pt reports she was woken up at 0300 this morning from the side effects, she feel sick, headache, have frequent urination, diarrhea and pain in her stomach and feeling nauseous. ***NOTE*** Recommend pt can take Ibuprofen PRN for her headache, to stay hydrated to prevent dehydration due to her her frequent bouts of urination and diarrhea, rest and consume some food to help with feeling of nausea. Advised pt these ADEs are common within first 3 days and should resolve in 1-2 days of symptoms onset. Recommend if symptoms does not get better to contact MD or seek medical care right away.  **Please follow up with pt after 11am** 5/2-Patient feeling better today. No signs and symptoms at this time. Patient has taken 600mg of ibuprofen as directed which helped  alleviate symptoms.
has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
08/24/22 presents to EC ED for "altered mental status, fall, fever". PMHx of "HTN, HLD, AAA, and a pacemaker"
Patient states she received the Pfizer vaccine on 04/10/2021 and a week later developed shingles.
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
3/26/03: Mom and Dad called to report redness and swelling on right arm at site of immunization's injection. Child playing - no fever - in no discomfort. Size of area 2" x 4". 3/27/03: redness and swelling now extending below elbow and radiating to shoulder/back area. Pt states it itches. Color has changed from red to light pink. No fever.