chrisvoncsefalvay/vaers-outcomes huggingface dataset:
What medicine do you recommend for aches and pains after getting the shot?; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported b patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient enquired which medicines are recommended for aches and pains after receiving Shingrix.
Pt recvd 2 doses of Engerix-B 21MAR91 & 21APR91 & devel a vaginal yeast infect following both doses & visited MD to receive treatment;
My 14 yr old son received his first dose of HPV vaccine. Blood was dripping down his arm after shot. Then while leaving doctors office his eye began rolling and he was about to faint and I quick caught him. He looked very pale almost grayish. He is acting fine since we arrived home. I really wish I didn't get him this vaccine.
Redness to Lt arm swelling, and pain with itching. Has cellulitis and allergic reaction to vaccine. Will be tx with KEFLEX TID and ATARAX QID.
Awakened with pain and swelling on the underside of the left arm all the way down to the elbow.  Became progressively difficult to bend elbow.  The swelling progressed to the wrist and finally resolved about 5 days later with the use of tylenol and ice packs.
PATIENT LIED  ON CONSENT FORM THAT THIS WAS THEIR FIRST COVID VACCINE, AND TO PHARMACIST AND CLERK WHO ASKED IF THIS WAS THEIR FIRST VACCINE.  ERROR WAS DISCOVERED DURING PROCESSING OF THE VACCINE PRESCRIPTION. WHEN PATIENT WAS CONTACTED, THEY ADMITTED THAT THEY HAD RECEIVED 2 DOSES OF PFIZER IN THE PAST.  THEY STATED THAT THEY HAD READ THAT THE CDC/DR. HAD RECOMMENDED BOOSTERS FOR IMMUNOCOMPROISED PEOPLE.  PATIENT STATED THAT THEY WERE IMMUNOCOMPROMISED DUE TO HAVING LYME DISEASE.
Swollen, red, warm, itchy, hardness at injection site about 2 inches across
Myalgia, Arthralgia, Fever, Rash, Diarrhea, chills Narrative:
Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with little mucus present; Burning in nose; Burning top of mouth; This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included multiple seasonal allergies, possible Crohn's disease, gluten sensitivity, allergic or sensitive to all antibiotics and prescription pain killers. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), hydrochlorothiazide, montelukast, and cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (batch/lot number was not reported), dose 1, administered in the right arm on 12Jan2021 (at the age of 69-years-old) 12:00 PM for COVID-19 immunization. The patient did not have other vaccines in four weeks. In Mar2021, the patient experienced severe inflammation of tendons in right ankle (especially primary tendon identified in MRI), nose bleeds, stuffy nose with little mucus present, burning in nose, and burning top of mouth. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment included antibiotic for sinus and boot for foot/tendon. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of severe inflammation of tendons, nose bleed, stuffy nose with little mucus, burning in nose and burning top of mouth cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
itch in legs, arms, hips, and all over his body; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 046A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS (thyroid medication).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included high blood pressure medication and thyroid medication.
Severe chest pain; Abdominal pain; inflammatory infection; Inflammatory infection; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administrated in Left arm on 23Jul2021 16:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jul2021 18:00, the patient experienced Severe chest pain, abdominal pain, inflammatory infection, nausea, and dizziness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was recovering.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
general itching, redness (flushed), diaphoresis, some shortness of breath, seen in ER, dx:  allergic rxn to FLUMIST
Unscheduled menstrual cycle started 10 days early.  Heavy bleeding and cramping.  Lasting up to 3 days.   Vomiting Headache
Mom stated that pt had developed blister on 8-14-14 with redness or swelling and didn't feel good all day. On 8-15-14 Mom brought pt into clinic and right upper arm was red with quarter size blister that had popped and several smaller blisters next to it. Mom said pt did feel better and that arm looked much better on 8-15-14.
started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19; started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19; patient had his booster on 16Dec2021 the day before symptoms started; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from quality group. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 (Lot number: FL3197, Expiration Date: 30Jan2022) at the age of 16 years as dose 3 (booster), single, administration date 25May2021 (Lot number: EP7533) as dose 2, single and administration date 04May2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19"; IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "patient had his booster on 16Dec2021 the day before symptoms started". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive; (18Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was given Tylenol.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101841610 same patient, different dose/event
Erythematous maculopapular rash with wheals 1-2 cm in diameter primarily over the shoulders, neck and upper back with just a few scattered on the trunk and legs
Facial tingling; facial tingling and numbness/cheek and eye feel swollen or numb; eye feel swollen or numb; eye feel swollen or numb; cheek and eye feel swollen; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the first dose of the COVID-19 vaccine yesterday morning at 9:00AM. The patient was experiencing facial tingling and numbness on unspecified date. He would like to know if this is a common side effect. He wanted to ask if numbness and tingling in the face a common side effect? The patient does not know if slept on his face or what but his left cheek and eye feel swollen or numb and stated that it was hard to describe. The patient noticed this this morning 15Jan2021. The patient stated, "it sort of feels like when you go to the dentist". The outcome of the event cheek swollen and eye feel swollen or numb was not recovered. The outcome of the remaining events was unknown.
Flu vaccine given around 5pm, woke from sleep with hives 9pm the same day. Came for appointment 9/26/13 (following day), still with moderate hives, BENADRYL PO prescribed. No SOB/wheezing.
TODAY IS DAY ONE OF THE SIDE EFFECTS.  FLU LIKE SYMPTOMS.  HEADACHE, OVERALL BODY MUSCLE SORENESS, SKIN SENSITIVITY, COLD WITH SHIVERS, LARGE RED CIRCLE ON LEFT ARM WERE VACCINE WAS ADMINISTERED. WEAKNESS AND FOGGINESS. ONE RED "DOT" HAS APPEARED ON MY LEFT LEG 2 INCHES ABOVE THE KNEE.  IT DOES NOT ITCH OR HURT.
Injection site hot; Injection site itchy; Rash a at the injection site; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash a at the injection site) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash a at the injection site) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and ERGOCALCIFEROL, RETINOL (A&D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Rash a at the injection site) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.            About 4-5 days after the second dose, the patient developed a rash a at the injection site, which was red, a circle about 3-4 inches, hot and itchy.  No concomitant medication was given.    Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up received on 09-May-2021 and does not contain any new information.
Chest pain and pain under left side rib cage. Shortness of breath and could not take deep breaths. Very labored breathing.
As part of the administrations actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized.
she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning). At the time of the report, VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided by the reporter.
Pt received GARDASIL and right after pt had a slight episode of near syncope for approx. 30 secs. Pt was layed down cool compress applied to head. BP checked and wnl. Pt was then examined by Dr. Pt was given crackers and water. Pt was observed for 30 mins then released.
SWOLLEN LYMPH NODE; FLU LIKE SYMPTOMS; BURNING EYES; VACCINE KNOCKED ME DOWN; BACK PAIN; HIP PAIN; This spontaneous report received from a patient 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  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. This report was non-serious.
INSOMNIA; INJECTION SITE REDNESS; FATIGUE; MYALGIA, MUSCLE PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old male. 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 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced injection site pain. On 29-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced myalgia, muscle pain. On 07-APR-2021, the subject experienced insomnia. On 07-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, fatigue, myalgia, muscle pain, insomnia, and injection site redness. This report was non-serious.
Persistent "lumps" about the size of a quarter bilaterally on each deltoid and in the underarm areas that are painful upon touch. Have remained the same size and have no change in color.
Mom states child has welt-like rash, that itches-vomiting & temp elevation - no thermometer;
Low grade fever and body aches for the next 2 days.  7 days after 2nd vaccine I developed a few small painful lumps  on my shins. By the 14th day the lumps had multiplied and gotten bigger and more painful.  One month later my legs we still in pain, hurt to walk/stand, more bumps had developed and the original lumps had started to bruise. All symptoms resolved  by the middle of April. Diagnosis with erythema nodosum.
patient was weak and pale .  could not sit . low BP  91/44 HR; 43 . sever arm pain on injection site .
He mentioned experiencing side effects like soreness of arm,/pain in his arm; swollen and pain in his arm; Headache; Hearing impaired; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just took the first dose of vaccine. On an unspecified date, he mentioned experiencing side effects like soreness of arm, swollen (also reported as not swollen, for clarification) and pain in his arm, headache and hearing impaired; nothing major. He also wanted to know if it is safe to take the multivitamins. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Suspected vaccination failure; Got the shot before I got it; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was thankful that he/she got the shingles shot before he/she got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Arm began to swell at 3pm 8/28/08. Blistering appeared on arm at site of vaccine (left tricep) at 10-11pm 8/28/08. Patient presented with mother to clinic at 9:30am, 8/29/08 with complaint of blistering, itching and burning sensation at site and burning sensation on left anterior and lateral aspect of lower leg. I, PHN, observed confluent blistering with irregular borders measuring 1.5cm by 3cm. Suggested palliative tx-ice, Domboro, calamine, benadryl for itching, cover with gauze to prevent scratching or transmission, keep clean, seek antibiotic tx if area becomes infected. acetaminophen if fever develops. RTC if worse.
Three days after injection, my arm developed red patches around the injection site. It was also warm to the touch.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-08-10.
Case number PHEH2015US002940, is an initial spontaneous report received from a nurse on 09 Feb 2015. This report refers to a 17-years-old female patient. Historical condition and concomitant medication were not reported. It was reported that before administration, MENVEO (batch number: M14030) was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014, MENVEO was stored at 55.1 degree Fahrenheit for unknown period of time and the patient was vaccinated on 18 Nov 2014 intramuscularly at a dose of 0.5 ml with this vaccine which was stored outside recommended storing temperature. No adverse event was reported following this administration error (incorrect storage of drug).
Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/16/2022 Discharge Date: Oct 19, 2022   PRESENTING PROBLEM: Dehydration [E86.0] Weakness [R53.1] AKI (acute kidney injury) (HCC) [N17.9]   HOSPITAL COURSE: Patient is a 76 y.o. male, with a PMH of ischemic cardiomyopathy, CHF, Afib, HTN, OSA, multiple myeloma, and primary appendiceal adenocarcinoma who presented to the ED with weakness. Patient was recently admitted from 10/8-10/12 with right septic olecranon bursitis/cellulitis treated with antibiotics, AKI and respiratory insufficiency due to COVID-19 infection. He was medically managed, weaned off oxygen, seen by PT/OT and discharged to home. At home he was not getting out of bed, not eating or drinking, and was weak without energy and brought back to the ER for further evaluation. On further interrogation he has been having diarrhea as well since starting Keflex and recent c.diff testing was negative. Given his weakness he was admitted to medicine for further evaluation.   He was found to have AKI. Given small fluid bolus, but AKI persisted. Workup consistent with pre-renal etiology with poor intake and diarrhea. Renal US without signs of hydronephrosis. Given more IV fluids and had resolution of AKI back to baseline Cr. He was evaluated by PT/OT who recommended home with assist. Given his good improvement he was discharged home in stable condition on 10/19/2022. He tolerated Keflex while inpatient and should complete previous course of Keflex at home.
3/30/07 Came in for vomiting, dehydration 5 days hx of vomiting, Admitted to hospital - CT scan revealed reg scan - transferred  for surgical evaluation. Had open reduction 4/3/07.  10/26/07 Reviewed hospital medical records which reveal patient experienced abdominal pain, vomiting, x 6 days; irritability, bloody mucusy stool x 1 day.  Admitted 4/2-4/5/2007. FINAL DX: Intussusception, surgically reduced; appendectomy.  Records faxed to CDC.
Erythema, induration, heat, pain ocurring 10 days after admistration. Varicella given IM rather than SC.