chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented with 4 cm  area of erythema around vaccine site that did not change with 30 minute vaccine monitoring.  ON exiting site pt told parent that throat "felt funny". Vitals 108/68 HR 100 oxygen saturation 98%. Lungs CTA. Heart tachycardic, regular throat- now swelling or erythema. Assess: stable for d/c with instructions to mom.
7JAN97 pt recv vax  & 9JAN98 mom called to report rxn & will bring pt to MD office;lt arm noted to be edematous from axilla to finger tip w/erythema to be edematous from axilla to fingertips w/erythema throughout;sent to ER;
Diarrhea start at 4:30PM, fever 101.3 to 102.7 start at 5PM. Malaise and very fussy.
After second dose of vaccine. Changes in menstrual cycle, began May 21 and ongoing. flushing and headaches, began May 21 - ongoing. followed up and reported to OBGYN August 2021. Increased pain and periods heavy, Skin itching, flushing, hot flashes, ongoing
The patient received 0.2ml of undiluted pediatric covid vaccine on 2/7/22 at 6:20pm. The mistake was found at 9pm that evening. The patient's father was call on 2/8/22 at 10am. The mistake was explained, the father said the patient did not have any side effects besides the normal sore arm where the injection was given.  I told the father to monitor her for the next few days for any kind of other side effects. I did not find a pediatrician listed on the patient's file to contact.
No additional AE reported.; patient received the first dose of GARDASIL 9 over a year ago; This spontaneous report as received from a pharmacist refers to a 17-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in 2020 (also reported as when 16 years old, over a year ago) the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route and lot# were not provided) for prophylaxis. On 30-JUN-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: 0.5 ml, strength, route and lot# were not provided) for prophylaxis (inappropriate schedule of product administration).  No additional AE reported.
Chest pain, palpitations, PAC's, short of breath, chest tightness, tingling in left shoulder/arm/little fingers, high blood pressure. 2 Emergency Room visits, admitted to hospital for monitoring.
Left arm is somewhat sore and possibly swollen at the site of injection, Injection site is slightly warm to the touch.
collarbone lymphnode swollen and sore; collarbone lymphnode swollen and sore; tiredness day of vaccination; This is a spontaneous report received from a contactable patient. A 32-year-old adult non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in her left arm on 13Mar2021 at 12:15 (at the age of 32 years) as a single dose for COVID-19 immunisation. Past medical history included obesity, sinus infection and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included Amoxicillin/clavulanic acid (AUGMENTIN) for sinus infection (day 7 or 10). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has a medical history of being allergic to nitrofurantoin (MACROBID) and sulfa drugs. On the day of vaccination, on 13Mar2021, the patient experienced extreme fatigue. 5-days post vaccination, on 18Mar2021 at 2000, the patient experienced left collarbone lymph node swelling and soreness. No therapeutic measures were taken in response to the events. The clinical outcome of the event lymph node swelling and lymph node pain was not recovered and the patient recovered from the event tiredness on 14Mar2021. No follow-up attempts are needed. No further information is expected
Flu vaccine was administer at 1300, associated notice redness, swelling and pain at around 1800 the same day of administer. Redness and swelling has decrease but still painful. 10cm x 10cm local reaction Lt Deltoid. No anaphylaxis.
I had  joint stiffness, my body ache, abdominal pain, diarrhea and headache.
Patient became pale and limp a few minutes after DTaP, Hibtiter, Prevnar given. Recovered spontaneously in approx one minute and was asymptomatic after that.
Injection site reaction/swelling/redness/pain/warmth to touch - ongoing abdominal cramping - ongoing febrile - ongoing muscle/joint aches - ongoing tachycardia - ongoing headache - ongoing
Patient presents to ED three days after receiving Moderna COVID-19 vaccine dose #1 at ER vaccien clinic reporting palpitations and lightheadedness. ECG similar to prior ECG. No chest pain, diaphoresis, nausea, or exertional symptoms. Blood pressure 139/96 mmHg, other vital signs within normal ranges. Patient discharged to home stable with symptom improvement.
This spontaneous report as received from a nurse via a company representative refers to her daughter, a 12-year-old female patient (currently 18 or 19 years old). No information on the patient's concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, in approximately 2009 (reported as "6 years or 7 years ago"), at the age of 12 years old, the patient was vaccinated with GARDASIL, (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, in approximately 2009 (reported as "then"), the patient developed long term headaches. The patient sought medical attention. Product quality complaint was not involved. The outcome of the event was not recovered/not resolved (reported also as "long term headaches"). The relatedness between the event and the GARDASIL was not reported. Additional information is not expected, as there was no consent to contact the physician.
Mother presents with infant who is happy, smiling and blowing bubbles to discuss onset of rash to anterior thigh 24 hours after receipt of 4/15/2016 PEDIARIX. Child also received oral rotavirus on 4/15/2016. Mom advised child was fussy x 24 hours but back to normal self by 4/17/2016. She saw HCP on 4/21 for routine f/u for 4/8 and 4/11/2016 visits where treated for URI/wheezing. He was cleared on 4/21 and received 2 of the 4 recommended vaccines for a 4 month old (mom prefers to split). Mom advised the rash was persisting but not getting worse. Providers document red papules and prescribed topical 1% hydrocortisone. Mom doesn't see much difference but has only applied it once. Child also has several small red raised macules to left thigh surrounding yesterdays Hib and PCV13 vaccinations. Mom denies any new foods (breast feeding only), no new detergents, soaps, lotions, creams, no dogs/cats, does have carpet but doesn't shampoo, etc. Mom advised the had been at the park prior to onset of rash and unsure if bitten by anything...was not placed on grass.
Immediately upon injection I felt a jolt of pain almost like I was shocked by electricity running down my arm. I knew to expect soreness and possible hardness, but as Friday evening wore on my upper left arm became completely engorged and sore. I looked like a body builder. I was barely able to move my arm. I took 2 TYLENOL and went to sleep thinking the swelling would go down. I woke up on Saturday morning and while the hardness had lessened some my arm was still extremely sore. I continued with TYLENOL and started icing my arm. When I went to change for bed on Saturday around 10 PM I noticed a large area of swelling and redness under my armpit extending halfway to my elbow. On Sunday I woke up and the pain continued to lessen, but the redness and swelling continued creeping closer to my elbow. I went to urgent care at 11 AM on Sunday where two doctors examined me to determine what was happening. As best they could tell it appeared to be an allergic reaction to the vaccine and not cellulitis. They were a bit puzzled why the underside of my arm was reacting and not the injection area. They marked my arm and told me to contact my regular physician and follow up. They prescribed prednisone, ALLEGRA, BENADRYL and an antibiotic if the redness spread. On Monday morning the redness had returned and the swelling had migrated outside the markings by the urgent care physicians. I sought help from PA. As the prednisone kicked in the swelling reduced and the redness dissipated. My arm began to bruise on Monday, 12/11/17.
No adverse event; A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.).    No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
This spontaneous report was received from a Licensed Practical Nurse referring to an 11 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 01-NOV-2017, the patient might have received a dose of PNEUMOVAX 23 (route, dose, frequency, and anatomical location were unknown) with lot # N014946 and expiration date 01-FEB-2019, instead of the prescribed dose of GARDASIL 9 (route, dose, frequency, and anatomical location were unknown) with lot # M041212 and expiration date 21-JUN-2019 for prophylaxis. The patient, was scheduled to receive the second dose of GARDASIL 9 in the 2 dose vaccination series. The nurse reported that GARDASIL 9 and the PNEUMOVAX 23 were not incorrectly administered due to product confusion, but that the vaccines may have been inadvertently administered to the wrong patient. No adverse effects reported. The is one of two cases from the same reporter. Sender's Comments: US-009507513-1711USA010364.
PATIENTS DAUGHTER CALLED TO REPORT THAT THE PATIENT HAD SEVERE STOMACH PAINS 20 MINUTES AFTER THE VACCINE, SUCH THAT SHE WAS DOUBLED-OVER AND REQUIRED INCREASED DOSES OF HER MORPHINE PRESCRIPTIOIN
Approximately 2 days after receiving vaccine, patient noticed generalized rash at site of injection as well as opposite arm and torso. Dermatologist diagnosed him with vaccine related "viral exanthem". Not allergic reaction. No hives, no urticaria.
I can still feel pain in my arm like they shot it in the vein instead of muscle.; This a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 11:15 (Lot number: Ew0153) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02May2021 11:15, outcome "not recovered", described as "I can still feel pain in my arm like they shot it in the vein instead of muscle.". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Reported that arm where shot was administered was painful like they shot it in the vein instead of muscle. It had been 3 months since the shots and could feel pain in his arm. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse and described an adult patient who did not respond to immunization with Hep-B.    The patient's medical history included renal failure (cause not specified) requiring hemodialysis.    On an unspecified date, the patient received a dose of Energix-B.  At an unspecified time following the administration of Energix-B on an unspecified date, a hepatitis B surface antibody titre was "less than 10".  The nurse stated that the patient "failed to seroconvert"
p/recv vax pt exp local react in arm described as 1.5'' in diameter & itchy.
Vaccinator asked patient if the dose was her Pfizer booster, which she said Yes, after administration, she looked at her new vaccine card and noticed that the vaccinator put that she received Pfizer. She then said she was supposed to get Moderna. Vaccinator checked original card and it said that the patient got Moderna as primary series.
Severe menstrual cycle- debilitating pain, severe nausea, dizziness, lightheadedness, fatigue, trouble standing and walking. Little relief from OTC medications.
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Ten minutes after getting the vaccination, the patient experienced syncope in the waiting room. Later that same day, she experienced abdominal cramps, cold sweats and diarrhea. The outcome was not reported. Additional information has been requested.
Chills/severe shakes; Chills/severe shakes; joint pain; vomiting 2 days/Nausea 4 days; vomiting 2 days/Nausea 4 days; diarrhea; congestion; Extreme headache 2 days/mild for up to a week with fuzzy head feeling; Extreme headache 2 days/mild for up to a week with fuzzy head feeling; little dizzy; would get a wheeze; then feel mildly out of breath for a couple minutes; twice felt mild chest pain briefly; hands tingling; extremely tired for 10 days; This is a spontaneous report from a contactable consumer(patient). A 57-year-old non pregnant female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 04Aug2021 18:15 (Batch/Lot Number: EW0180)(at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included Other medical his Heart murmur, controlled BP, Allergic reactions to many drugs/environmental, take sublingual drops, Diverticulum disease, testing for hyperparathyroidism. The patient had Known allergies to Azor, Biaxin, Cardizem, Crestor, Cipro, Exforge, Ibuprofen, Lipitor, Sulfa, Tetracycline, Topamax,Ventol, Lisi. The patient concomitant medications include spironolactone (ALDACTONE ), ezetimibe (ZETIA), doxazosin mesilate (CARDURA), hydralazine(HYDRALAZINE), cetirizine hydrochloride (ZYRTEC) ) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 was unknown. The patient had not tested covid post vaccination. On 04Aug2021 10:00 PMthe patient experienced Chills/severe shakes, joint pain, vomiting 2 days/Nausea 4 days, diarrhea, congestion, Extreme headache 2 days/mild for up to a week with fuzzy head feeling, little dizzy, would get a wheeze and then feel mildly out of breath for a couple minutes, twice felt mild chest pain briefly, hands tingling, extremely tired for 10 days.The patient not received treatment for AE. Outcome of the events was recovering.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
nausea for a couple of minutes; felt sick; threw up flem; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient had no known allergies. On an unspecified date,  Patient was feeling nausea for a couple of minutes. She was sitting still and all of a sudden, she felt sick and she threw up flem. But after that, she was fine. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
w/in 24hrs of vax pt devel large, indurated, erythematous area @ site; size of local rxn was about 4" in diameter
Weak; Legs could not carry her; Looks like a sunburn; Rash; Itchy vaccine arm; Pain on the injection arm; Painful joints; Shooting pain in head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash) and VACCINATION SITE PRURITUS (Itchy vaccine arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash), VACCINATION SITE PRURITUS (Itchy vaccine arm), VACCINATION SITE PAIN (Pain on the injection arm), ARTHRALGIA (Painful joints) and HEADACHE (Shooting pain in head). The patient was treated with CALAMINE for Itchy, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash), VACCINATION SITE PRURITUS (Itchy vaccine arm), ARTHRALGIA (Painful joints) and HEADACHE (Shooting pain in head) outcome was unknown and VACCINATION SITE PAIN (Pain on the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include unspecified Thyroid medication  It was reported that patient felt pain is still on and off.   This case was linked to MOD-2021-222545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information was received from initial reporter: reporter mail ID was added
Developed approx 20 red papules on trunk, thighs and neck. Calamine lotion and Benadryl as needed.
He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 08:30 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2017 (unspecified if ongoing); "Spleen removed", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN6205), administration date: 20Mar2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine".  Additional Information: The patient received any other vaccines within 4 weeks prior to the covid 19 vaccine was unknown. The patient received any other medications within two weeks was unknown.  No follow-up attempts are possible. No further information is expected.
Had Rash that oozes, arms and legs, what appears to be contact dermatitis, but never had before, given steroid inj but did not help, flares up if eaten even a small amount of corn syrup or corn starch product.
No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, diffuse rash on face, neck and chest. Day 3 following vaccination, rash worsening and spreading to arms; also cold feet, especially toes. Day 3, met with telehealth physician who prescribed prednisone 40 mg once daily for 5 days and diphenhydramine 50 mg TID.
Welt of the size of a lime in the injection site; Red mark; Hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site), INJECTION SITE ERYTHEMA (Red mark) and VACCINATION SITE PAIN (Hurt to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ANTIHISTAMINES for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site), INJECTION SITE ERYTHEMA (Red mark) and VACCINATION SITE PAIN (Hurt to touch). On 29-Jan-2021, INJECTION SITE URTICARIA (Welt of the size of a lime in the injection site) and INJECTION SITE ERYTHEMA (Red mark) had resolved. At the time of the report, VACCINATION SITE PAIN (Hurt to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use also included stomach medication. Treatment for the events included Tylenol (acetaminophen) and cold applied on the injection site.   This case was linked to MOD-2021-041652 (Patient Link).
Significant stomach cramping, nausea and diarrhea following second dose of vaccine. Elevated temperature of 100.1 degrees F.
Information has been received from a certified medical assistant concerning an adult (age and gender not reported) pt who in approximately Oct 2005 (over the last month), was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently, on an unspecified date, the pt developed an injection site reaction to include soreness, warmth, erythema and swelling. The patient was treated with antibiotics and an on unspecified date recovered fully. The patient experienced was considered to be other important medical event by the reporter (OMIC). Additional information has been requested.