chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day, the patient reported shingles on the temple of her right side, moving to the forehead / toward the eye /  diagnosis of shingles; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine headache.   On 25th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th February 2021, 1 days after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient went to see her physician for a migraine headache. The physician gave her a dose of Shingrix as part of her annual exam. The next day after receiving vaccine, the patient reported shingles on the temple of her right side, moving to the forehead and toward the eye. The patient went to urgent care and a diagnosis of shingles was made. The patient was given anti-virals and discharged.  On 1st March 2021 Monday, the patient went to see an ophthalmologist, who confirmed shingles again, but noted it did not get into the eye. Steroid drops were prescribed and symptoms were still present till the time of reporting. Formulation of Shingrix was not known, nor the lot number. The patient required emergency visit. The reporter consented to follow up.
Injection site pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), lot no. EK5730, intramuscular (right arm) on 07Jan2021 11:30 at a single dose for COVID-19 immunization at a hospital. The patient had no relevant medical history. She had no known allergies. Concomitant medication included colecalciferol (VITA D). No other vaccine in four weeks. No COVID prior vaccination. The patient experienced injection site pain on 07Jan2021 12:00 PM. No treatment received. No COVID test post vaccination. The patient recovered from injection site pain on an unspecified date.
This case was reported by a nurse via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date for tolerance see case US2018GSK178839). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was recovered/resolved.  It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The case was reported by nurse for herself. The age at vaccination was not reported. The age group was not reported, but was captured as adult as per vaccine indication. The patient experienced fever of 101 degrees Fahrenheit which lasted 2 days. No additional information were provided. Lab Comments: On an unspecified date, the patient's body temperature was measured.
About 2 hours after getting the shot, I developed a red spot on the botton of my right eye.
Patient was administered vaccines at 10:50am on 4/28/2022. A red rash appeared at 11am on patient/'s forehead, right shoulder, bottom of bilateral feet on the plantar surface, bilateral shins, right hand and posterior neck. Rash appeared red and in patches. No visible difficulty breathing, restlessness, itching, fever although patient is warm to the touch, absence of any other symptoms. No reaction at injection sites. Patient was monitored for 40 minutes after vaccine administration, patient was discharged at 11:30am with almost complete resolution of rash. Remaining rash was observed on the plantar surface of the right foot.  Benadryl was offered at 11:20am, parents declined Benadryl at this time.
At first, no arm pain.  About 4 hours later ....very fatigued, plus swollen hands ....slept for about 2 hours ...when awake ...no further symptoms.  Since that afternoon real arm pain for the next two days, then gone. I am emailing these side effects because I could not get into the VSafe response system to report these side effects.  Thank you.
Within 5 minutes of vaccination client started developing hives, and reported discomfort in throat and feeling like throat was going to close.  Epinephrine administered, IV Benadryl and Solumedrol administered. Client reported feeling better post-epinephrine. Client transported to ER for further evaluation.
PT woke up Tuesday morning about 48 hours after her first Covid-19 vaccination with persistent chest pain. She described it as pin-point, in the Sternum area and constant. When asked to describe her level of pain out of 10, she described it as a 7 or 8.  It worsened upon forcing herself to take a deep breath, a forced cough (she was not coughing and had no other symptoms but upon a forced cough) and also when laughing. She had no other symptoms, no fever, no cough or Upper respiratory, and no known exposure to Covid-19.  Her only complaint was persistent chest pain, and heaviness.  I (her mother) called the pediatrician and we were advised to go to ER or urgent care. We have a specialty Urgent Care in local suburb of, so we went there first. Upon examination by the physician (Dr., MD) PT was diagnosed with Precordial Pain and recommended for referral to local ER for STAT bloodwork (urgent care in PA does not have that capability). Thus we then went to the ER at Hospital where pt. had the work up  listed below. PT was discharged from the ER with instructions for her to make a follow up appointment with a pediatric cardiologist for an Echo Cardiogram and or MRI (hospital did not have capability) and to not get the second dose until the Cardiology appointment. She has follow up appointment at (Hospital) at the location but not until their soonest on 12 Oct 2021.
bloody stools; A spontaneous report was received from an unknown reporter concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), experienced bloody stools for 2 days.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 05-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) for prophylaxis of COVID-19 infection.     Patient reported to the nurse at his second Moderna vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event, blood stools for 2 days , was recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Pt vaxed w/Hep B vax (recomb) on half the usual dosage of hep B vax (recomb) on 30OCT90 & 31OCT90; On 27NOV90 recvd 2nd dose of vax 1ml; @ time of report there was no adverse rxn; No further details were provided;
AFTER GETTING THE VACCINATION  (WITHIN 24HOURS) PATIENT REPORTED THAT SHE COULD NOT LIFT HER RIGHT ARM ABOVE HER HEAD, NOR PUT IT BEHIND HER OR PLACE IN HER POCKET WITHOUT EXTREME PAIN. PATIENT REPORTED, WHAT I WOULD CALL, NORMAL BRUISING AT THE INJECTION SITE. PATIENT REPORTED THIS TO ME TODAY 3/14/18. SHE HAS SINCE GONE TO PHYSICAL THERAPY, YESTERDAY, WHICH HELPED THE PAIN. SHE SAID WHEN SHE GOT UP THIS MORNING IT DID NOT HURT, BUT IT DOES AGAIN NOW. PATIENT IS GOING TO CONTINUE WITH PHYSICAL THERAPY.
Information has been received from a consumer concerning her 85 year old husband with seborrhoeic dermatitis on scalp, uses pacemaker for an irregular hear beat and history of right knee replacement who on approximately 12-Aug-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included warfarin sodium (Coumadin), potassium chloride (K-Lor), furosemide, metoprolol succinate (Toprol XL Tablets), omeprazole (MSD) and candesartan cilexetil (Atacand).  On approximately 05-Sep-2007 the patient developed a rash on his lower back.  The patient also developed a bunch of individual rashes which were raised a bit and red in color.  The rashes were causing quite a bit of itching.  The patient had not seen the physicians and the reporter was not sure if the patient had shingles.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
30 min after above immunization and given Similac sensitive (pro) pt got hives, red, fussy felt hot. Pt returned to office about 1 hour after rash got BENADRYL, DECADRON observed. Much improved.
Light sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Light sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant in February 2021. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced PAIN IN EXTREMITY (Light sore arm). At the time of the report, PAIN IN EXTREMITY (Light sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient also takes many other antirejection medications.  No treatment medications were reported.  Patient had a light sore arm, the following day it was a little bit more and patient did not take any medications.   This case was linked to MOD-2021-320754 (Patient Link).
About two weeks after getting my first shot, besides the typical pain at the injection site ( felt like a decent punch to the arm for about 1 week), I had the sensation of having an abscessed tooth. I?ve had an abscessed tooth before and the sensation was the same. Both sides of my jaw were very sore, hard to open my mouth,  pain radiating up my jaw and into my ears on both sides of my face. The next day my face muscles ?dropped? like they became too relaxed and it seemed to me exactly like my abscessed tooth from the past. I had started to take some antibiotics that I have on hand in preparation for a visit to the oral surgeon. Three days of this and the pain and my muscle issue disappeared. I should note that I lost my taste throughout the three days that this happened. Everything is normal since, just wanted to bring this up and report this strange reaction.
Found in cardiac arrest at his residence. Brought into the emergency department by ems in cardiac arrest. No return of spontaneous circulation. Pronounced dead at 0746.
Information has been received from a consumer concerning a 79 year old female who in May 2006, was vaccinated SC with a 0.65 mL dose of Zostavax (Oka/Merck).  Six months later, in November 2006, the patient developed a rash on her arms and legs on the right side of her body.  She also had a severe nerve pain from the back of her neck that "ran all the way up."  The reporter could not supply the lot number.  Unspecified medical attention was sought.  "Nerve tests" and "dermatology tests" were performed (results not provided).  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  No further information is available.
Patient came to the pharmacy today and complained about the side effect of the vaccination that she received on 4/11/2019.   At the injection site, the redness spread out up to almost 4 inches.  It was warm and tender. Patient also complained about itchiness around the injection site.   She was advised by the pharmacist to apply cold compress for the swelling; Benadryl to take care of the itchiness and Tylenol as needed for the uncomfortable.
Information has been received from a mother concerning her 4 year old daughter with no known allergies who in December 2001, was vaccinated with a dose of MMR (lot # 640791/1210L). The patient may have had a cold at the time of vaccination. There was no concomitant medication. In December 2001, the patient developed a high fever for several days (101.4 degrees F), a rash all over her body, and ulcers in her mouth. The mother also reported post vaccination the child was diagnosed in the autism spectrum specifically pervasive developmental disorder and semantic pragmatic disease. The patient did improve. It was reported that the child is due for her next booster. Unspecified medical attention was sought. No product quality complaint was involved. Pervasive developmental disorder and semantic pragmatic disease were considered to be other important medical events (OMIC). Additional information has been requested. Per follow up report received on 06/14/2005:  Patient still has not recovered.
This spontaneous report was received from a registered nurse and refers to a 26-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB, 5 mg / 0.5 ml (pediatric dose), (route, anatomical location, lot# and expiration date were not provided). Then, on an unknown date, the patient was vaccinated with a second dose of RECOMBIVAX HB, 5 mg / 0.5 ml (pediatric dose), (route, anatomical location, lot number and expiration date were not provided), for prophylaxis. The reporter stated that the patient received the third dose of RECOMBIVAX HB on an unknown date in an adult formulation. No adverse effects were reported. The reporter also stated that the patient "will be getting titers in 2 months". Product quality complain (PQC) was not involved. No other suspect or concomitant therapies were reported. Follow up information was received on 28-FEB-2017 from the registered nurse. She stated, that she was unaware of any adverse effects reported regarding the administration of RECOMBIVAX HB. Additional information has been requested.
This spontaneous report has been received from a licensed practical nurse referring to a female patient of an unknown age. Information regarding the patients' current conditions, medical history, and drug reactions or allergies was not provided. On an unspecified date in 2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, anatomical location and route were not reported) for prophylaxis. The patient's concomitant therapies were not provided. It was reported that on approximately15-MAY-2017 (reported as "about one week ago"), the patient was vaccinated subcutaneously on an unspecified arm, with the second dose of GARDASIL 9 lot # M034780 and expiration date 15-MAY-2019. No adverse effects were reported. Additional information has been requested.
localized swollen, painful, tight and red arm (4 days), tiredness, chills, bodyaches for 1-2 days
swollen lymph nodes in neck, and general swelling in neck. this lasted for two weeks. At points during that time my lower jaw was numb.  Extreme headaches and stiff neck. Headaches would wake me in the middle of the night. Extreme exhaustion. Also I started having extreme digestive problems. Upper abdomen would spasm and go rigid. When this happened my heart would race and my blood pressure would go up. Had two weeks of zero appetite, and had trouble tolerating food for a month.
C/O headache lasting 1-2 hrs after vaccine. Relieved with TYLENOL and sleeping. Received HPV, Tdap, MCV4 on 4-17-2014. Mom reported sxs today 4/17/2015 at physical visit.
At 03:45 pm Mom called stating that child has a rash after receiving shots ( 1 hr after ).
pt recv vax; erythema 11cmx11cm rt arm at inject site; motrin given;
Numbness in face; Burning in skin in bottom of arm from armpit; Severe lymph node swelling; Severe fatigue; This is a spontaneous report from a contactable consumer reported for patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6202, Expiration date was not reported), via intramuscular in arm on 24Feb2021 at 09:00 (at the age of 39-year-old) as a dose 1, single for COVID-19 immunization. The family medical history was reported as none. The patient's medical history included sarcoidosis, on an unspecified date in 2011, sarcoidosis diagnosed 10 years ago and high blood pressure. The patient's concomitant medications included metoprolol, 25 mg, 2x/day, taken for high blood pressure. Stated that, he has been on it for a year and a half. No previous history of all immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. AE following prior vaccinations were reported as none. It was reported that, call was received from the consumer regarding the Pfizer COVID 19 vaccine. Stated that, she would like to know about recommendations on getting second dose for her husband. Stated that, he was due for second shot tomorrow. He was scheduled for his second dose tomorrow and wanted to know whether he should get it or not. Was there a recommendation to proceed with second dose given he still has swollen lymph nodes. Stated that, her husband's name was (name withheld). He received first dose on 24Feb2021 at 09:00. Three or four days after receiving, he started to get severe lymph node swelling as well as numbness and burning in skin and pretty severe fatigue. It was reported that, on 24Feb2021 at 11:00, the patient experienced severe fatigue, severe lymph node swelling on 28Feb2021 at 21:00, numbness in face on 15Mar2021 at 05:00 and burning in skin in bottom of arm from armpit on 15Mar2021 at 00:00. The event severe lymph node swelling was reported as worsened. Stated that, there was no prescriber. Stated that, he has a pre-existing condition, so he was up for the phase they were in. She thinks the burning in skin and numbness are related to the swelling in lymph nodes. Stated that, his condition of Sarcoidosis was in 2011. He received the vaccine in the top of arm closer to shoulder. Stated that, no emergency room or physician's office required. Stated that, they called his physician and said to keep an eye on it. If it persisted past next Monday to come in. Also reached out to location they received vaccine and they provided them with Pfizer Drug Safety's number. No relevant tests were reported. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Initial report received from a patient on 19 April 2007. A 62 year old, female patient developed hives, 4 days after receiving DECAVAC (lot number U1703AA, route of administration not reported) in the left arm on 19 December 2006. She took some homeopathic allergy drops and she stated "they kept coming back". She was evaluated by a physician on 31 December 2006 and given a "shot of something". She was also seen by a homeopath as well. The homeopathic computer indicated "tetanus" probes. It was reported that she recovered.
My son is vomiting non stop and fever; My son is vomiting non stop and fever; Dose 1: 26May2021; Dose 2: 09Jun2021; This is a spontaneous report from a contactable consumer (Patient parent). A male patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 09Jun2021 at 14:00 as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Celiac. Patient had known allergies Celiac disease. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in Left arm on 26May2021 at 15:00 for COVID-19 immunisation. On 10Jun2021 at 12:00, reporter son (Patient) experienced vomiting nonstop, fever and Inappropriate schedule of vaccine administered. AE did not result in physician office and emergency room. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Information has been received from a physician concerning a 12 year old female who on 21-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) in the right arm (route not reported. There was no concomitant medication. On 21-JUN-2008 the patient experienced numbness and parathesias. The symptoms were a little better when the patient got home. The patient sought medical attention in the office. Additional information has been requested.  9/2/08 WCC received from PCP dated 6/21/2008 which states mother refused HPV vaccine. TDaP, Menactra and Varicella vax rec'd on that date. 9/26/2008  Per office RN pt recently in for 2nd HPV vax, no reported problems.  Case closed.
Pain in temple, temple is sensitive to touch. There's a pain in my temple when I talk, bite, or hold my jaw. I've never experienced this in my life before.   I'm also hearing a constant ringing in my ears.
This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
she is experiencing swelling and had rashes all over the body; she is experiencing swelling and had rashes all over the body; This is a spontaneous report received from a contactable female consumer (patient). A female patient (unknown age) received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 22Apr2021 at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, after receiving vaccine the patient experienced swelling and had rashes all over the body. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderate facial swelling, generalized. Noticed when got up from bed approximately 24 hours after dose given. The facial swelling may have started about 5 hours post vaccine as didn't look in the mirror until 24 hours post. I have been taking Diphenhydramine 25mg and Ibuprofen 400mg every 8 hours since one hour before the vaccine was administered as history of having Long-covid and unsure of reactions. The facial swelling subsided anywhere between 4-15 hours after initial presentation. I am continuing to take Diphenhydramine 25 mg every 8 hours and has helped with the swelling. The facial swelling is almost completely resolved.