chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/11/07 Redness of right upper arm, axilla, elbow and below elbow, Edema right elbow, painful. Nothing at 12/13/07 right arm and elbow reddness, edema, pain has decreased. Dx - cellulitis - duricef 500 bid.
rash dx as shingles;started on 18MAY98;got varivax 7JAN98;
This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # M038216 with expiration date 09-MAY-2018 (dose and route of administration were not reported. The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information had been requested.
5/22 PATIENT RECIVED ZOSTAVAX VACCINE. 5/23 PATIENT RECIEVED RX FOR ACYCLOVIR 800MG 5XD FOR 10 DAYS FROM URGENT CARE DIAGNOSIS SHINGLES RASH ON THE STOMACH. THE PATIENT STATED THAT ON 5/22 BEFORE RECEIVING THE ZOSTAVAX VACCINE HE HAD WHAT HE DESCRIBED AS A SUNBURN ON HIS STOMACH. HE STATED HE DID NOT THINK ANYTHING OF IT AT THE TIME AND DID NOT MENTION IT TO US BEFORE RECEIVING THE VACCINE. THERE WAS NO LOCALIZED REACTION AT THE INJECTION SITE.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having a reaction) 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 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION COMPLICATION (Having a reaction). At the time of the report, VACCINATION COMPLICATION (Having a reaction) outcome was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-110031 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-110031:Case for mother.
No additional AE were reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report as received from a healthcare worker refers to a 4-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 29-AUG-2022, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # W002562 with expiration date 12-OCT-2023 or lot # W004504 with expiration date 16-JUN-2023 (the patient received only one dose but the healthcare worker did not specify which actual lot number the patient received) (exact dose was not reported) as prophylaxis (product storage error). The vaccine was stored in the temperature of 11.3 degrees Celsius for 34 minutes. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
FEVER PEAKING AT 40'C; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-JUN-2021, the subject experienced fever peaking at 40'c. Laboratory data included: Body temperature (NR: not provided) 40'C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever peaking at 40'c was not reported. This report was non-serious.
Patient called today to report on reaction. Per patient, has a high pain tolerance level. Pt noticed on Wed/Thurs. (04/11/18) a slight itch on neck, swelling and a pink color at injection site, pt also noticed itch and rash around lymph nodes area of neck, and groin area. Rash/itch persisted on Saturday and patient took a BENADRYL, got better but once BENADRYL wears off, pt feels itchy again. On Sunday (04/15/18) pt noticed lips a bit swollen, pt took a chlorpheniramine and got better. As of today, 4/16/18, still is still present, all over, but getting better. Lips no longer swollen as of today. I encouraged patient to notify PCP of reaction and call 911 if symptoms ever get worse (lips swelling or difficulty breathing, etc.).
Initial unsolicited report received from a nurse on 31 Oct 2017 and additional information received on the same date. This case involves a 43-year-old female patient who was vaccinated with 0.5 ml one dose of ADACEL (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 27 Oct 2017. The patient had allergies to sulfa (rash) and codeine (Nausea). Other medical history was not reported. Concomitant medications were not reported. (It was reported as Unknown if other vaccines were given at the time). On an unknown date, within few hours after the vaccination, patient developed severe headache, nausea, stiffness in neck and lethargy. On 31 Oct 2017 at midnight, four days after the vaccination (also reported as 3 days later), patient had a pounding headache, pain in her left eye, and she fainted at work, due to which the patient was brought to ER room and on an unknown date, the patient was hospitalized. Patient lab tests include an elevated ESR (erythrocyte sedimentation rate) level of 25. Corrective treatment was not reported. Outcome of all the events were unknown and details about hospitalization was not provided. It was reported as the patient treating MD determined patient reactions was related to receiving vaccine ADACEL. List of documents held by sender: none. Sender's Comments: Patient developed severe headache, nausea, stiffness in neck, lethargy and syncope after vaccination with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset was compatible. Patient's medical history was reported as allergy to sulfa and codeine but tolerance to previous vaccination was not provided. The events could be due to an underlying etiology that is unrelated to vaccination. Patient's medical condition at the time of vaccination should be assessed and all alternate infectious and non-infectious etiologies should be ruled out. Based upon reported information the role of the vaccine cannot be assessed.
No additional adverse events.; Nurse reports an 11 year old patient was inadvertently administered PEDVAXHIB  instead of MENVEO (unknown manufacturer); This spontaneous report was received from a registered nurse, referring to a 11-year old male patient. The patient's medical history, concomitant medication and concurrent condition were not provided.     On 03-AUG-2020, the patient was inadvertently administered haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S031500, expiration date 21-APR-2022; strength, dose and route were unknown) for prophylaxis instead of meningococcal acyw conj vaccine (crm197) (MENVEO) (wrong vaccine administered). No additional adverse events.
Hives noticed on Right arm near elbow area at 15 min after vaccine gave patient 1 capsule of Diphenhydramine immediately, had pt. wait 10-15 min, redness was less & swelling came down; pt. released to home w/Rx for BENADRYL q 6 hours PRN.
Patient was accidentally given a 3rd dose of Rotarix. He had no adverse reactions and no treatment was needed.
LEGS ACHY/LEGS HURT MY BODY; SLIGHT FEVER; SLEPT A COUPLE OF HOURS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced slept a couple of hours. On 27-MAY-2021, the subject experienced legs achy/legs hurt my body. On 27-MAY-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, legs achy/legs hurt my body and slept a couple of hours was not reported. This report was non-serious.
Fever, muscle aches, weakness,  injection site and right wrist hurt for 48 hours
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There were no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was vaccinated in clinic and waited with mother for 15 minutes, no adverse reactions were noted. Patient's mother came back to the clinic one week later for a separate appointment and stated that patient had redness, swelling and a bump at the injection site on patient's left arm the day following the injection.  Patient did not have a fever. Mother gave patient heat pack, ice pack and Tylenol on Thursday.  Patient's mother gave  Benadryl on Friday (10/13/23.)  On 10/18/23, patient still had a bump at the injection site but no redness or swelling.
Dermatitis bullous; Erythema; Peripheral swelling; Pruritus; Somnolence; Hypertension; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DERMATITIS BULLOUS (Dermatitis bullous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (Dermatitis bullous) (seriousness criterion medically significant), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension). At the time of the report, DERMATITIS BULLOUS (Dermatitis bullous), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement (120-80): 140/105 (High) BP 140/105mmHg and 155/81 (High) 155/81mmHg. On 29-Mar-2021, Heart rate: 80 (normal) 80 bpm and 82 (normal) pulse 82 bpm. On 29-Mar-2021, Oxygen saturation: 98 % (normal) SpO2 98% and 96 % (normal) SpO2 96%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had red rash and swelling on both arms, mildly itchy. Extended below shot injection site to finger tips. Increased itching under left arm as well as mild itchy on torso. Alert and oriented. No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
This case was reported by a consumer and described the occurrence of sickness in a 68-year-old female patient who received Influenza vaccine. Co-suspect products included BREO ELLIPTA inhalation powder for chronic obstructive pulmonary disease. Concurrent medical conditions included chronic obstructive pulmonary disease. On 7th October 2014, the patient received Influenza vaccine. On 1st April 2014, the patient started BREO ELLIPTA (unknown) 100/25 ug at an unknown dose at unknown dosing. On 7th October 2014, less than a day after receiving Influenza vaccine and 189 days after starting BREO ELLIPTA, the patient experienced sickness. The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine and BREO ELLIPTA.
No adverse effects reported; a patient received improperly stored Varivax; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S002874 and expiration date 29-JAN-2021 (dose and route of administration were not reported) for prophylaxis. The temperature was from 6°F to 14°F (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005223: US-009507513-1909USA005220: US-009507513-1909USA005078: US-009507513-1909USA005119: US-009507513-1909USA005124: US-009507513-1909USA005129: US-009507513-1909USA005134: US-009507513-1909USA005139: US-009507513-1909USA005365: US-009507513-1909USA005525: US-009507513-1909USA005424: US-009507513-1909USA005468:
Patient came to pharmacy with wife for a FLUZONE HD vaccine, and was given BOOSTRIX vaccine in error. No treatment necessary or adverse effects noted by patient.
Information has been received from a consumer concerning her 22 week old grandson who on approximately 29-NOV-2007 was vaccinated (route and site not reported) with Hib conj vaccine (OMPC) (lot# not reported). Per the grandmother, the patient received his 4 month check-up vaccines developed "bumps on both of his thighs where the injections were given". Patient's grandmother was unsure which vaccines the patient received 2 weeks ago and thinks it was the Hib conj vaccine. It is unknown if the patient received medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Severe chills for 3 1/2 hours a fever for about three or four hours after chills, then vomiting and continuous fast heartbeat of between 144-167 beats per minute and pounding.  The fast heartbeat continued through the total of the next day.  The other symptoms ceased.  I should have gone to doctors office or called my doctor but didn?t,  thinking it would just go away. I took extra metoprolol hoping to tone it down.  The 3rd day heart rate is decreasing to 79 beats per minute.
Patient reported developing swelling and redness of right arm and glands under the arm.  Patient stated that it was difficult and painful to raise her arm.  Patient stated she used ice packs and antibiotic cream on her arm with some improvement in symptoms.
4OCT96 pt recv vax & 5OCT96 exp red, swollen, hot to touch, fever;swelling for a wk, itched, small bruise;21OCT hard lump now;no other c/o or problems @ this time;fever lasted over weekend only;
This case was reported by a nurse and described the occurrence of passed out in a patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the passed out and dizziness were unknown. It was unknown if the reporter considered the passed out and dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer also stated she contacted the vendor. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Health at provided address. This case is 1 of the 4 cases reported by the same reporter.
chills very bad pain in left arm from shoulder down to left muscle, coughing, tiredness, sleepiness,  nauseous, muscle pain in both legs, pain in both ribs.
patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The patient administered expired vaccine which was initially stored on 04-NOV-2021 patients were administered with dose in which some vaccinated on 05-NOV-2021 and 12-NOV-2021. The vial did not undergo any temperature excursions.34 patients and 16 staff members  were administered from an expired vaccine.2 patients have passed  away. No treatment drug were reported.
Stated redness, swelling, tenderness and welts on arm starting day after received flu shot. By the next day started looking better with welts and redness decreasing. On 10/14 patient states all redness and swelling gone.
per patient, pregnancy unknown at time of vaccination; came for flu shot 11/14/21 and told pharmacy staff she was approximately 7 weeks pregnant as of 11/14/21 so she may have been 2 weeks pregnant at the time of 2nd dose of MMRII; delivery date and birthweight unknown.  Patient was to follow up on 11/15 or 11/16/21.
Couldn't sleep, Fever, chills, weakness,( pins & Needles feeling) - (tingling), in hands & feet similar to neuropathy.  Went to ER aprox. 2:30am  home 6:30am took 2 Tylenol every few hours total 6 Tylenol. Adverse reaction lasted about 10 hours
Palpitations- Pt. reports that about 10 days after 1st moderna vaccine she had several days of feeling kind of off, with headache, body aches, very brief intermittent palpitations and a feeling of needing to take a deep breath (not really dyspnea) sx resolved then the day after her 2nd shot she had exact same symptoms for several days, currently basically resolved with just some mild sx remaining. Given the timing of these symptoms and the fact that they are essentially resolved does seem like vaccine reaction, normal exam today so will watch/wait and if it happens again or continues to will do appropriate w/up (holter monitor etc..)
Erythema, swelling, pain and heat at injection site, swelling decreased overnight, but erythema spreading, started on Benadryl and Bactrim.
Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready for bed by first going into the bathroom. While getting ready I passed out (micturation syncope). Hit my head on the floor and sustained a concussion. I am still experiencing post concussive symptoms but this is to be expected as it has been less than a week.
Injection site hardness; injection site appears like a cellulitis; Injection site feels warm to touch; injection site redness; injection site sore, achy/painful; injection site swollen/severe swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site sore, achy/painful) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy. Concomitant products included VITAMIN B COMPLEX, VITAMIN D3 and BIOTIN for Supplementation therapy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling). On 17-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (injection site appears like a cellulitis). On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hardness). At the time of the report, INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to urgent care on 17-Jan-2021 and saw a nurse practioner who diagnosed the patient's symptoms as cellulitis of right arm at injection site. The patient was prescribed with Cephalexin 500 mg 4 times a day for 10 days and the symptoms resolved.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: The significant follow up case was received on 07-APR-2021. Concomitant medications are added. Events  are added.
p/vax pt exp rash; devel on neck  series of small bumps; form on large thickened rough areas; very irritated mildly itchy;
Tinnitus - ringing in the ear. Began approximately one week after shot, got continually worse 12 days after. Went to doctor 15 dayts after. Prescribed amoxicillin and Fluticasone Propionate. After a week, had hearing check by audiologist and saw Physician Assisstant. Left hear showed dangerous signs of not hearing...more than right ear. Received Prednisone and continued with Fluticasone propionate.Doctor was concerned with Meniere's disease. Went back 2 weeks later, left ear more in tune with right ear, which was good. Doctor said nothing more could be done and would have to get used to the ringing. Brain would start to ignore in 4-6 months.
mom gave APAP a/inj;pt was fussy;grandma states acted like didn't feel good;no redness @ inj site;hot to touch-temp not taken;8PM pt started jerking;