chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Facial Paralysis, Loss of Muscle Tone, Sagging Cheeks, Loose muscles.
This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a RN concerning a 42 year old female LPN who on 03/18/04 "accidentally got an eye splash in the right eye" with MMRII (Lot # not available).  The pt was treated with a "water eye rinse". The nurse reported that after the eye wash the pt's eye felt like sandpaper had scratched it. It was unknown if the pt recovered. The pt sought unspecified medical attention. No product quality complaint involved.  Upon follow-up the RN reported that while the LPN was administering the measles virus vaccine live (+) mumsp virus vaccine live (+)  rubella virus vaccine live to a patient at 3:40 pm it was inadvertenly splashed into her right eye. The nurse flushed her eye for 1 minute with water. The nurse's eye became dry and "scratchy." Approximately 9 days later the nurse was diagnosed with blepharitis. It was unknown if the nurse recovered. No further information is available.
Third dose caused chills; third dose fever; third dose aching to the bone; third dose muscle fatigue; third dose kidneys hurt; first dose lymph node swelling in arm; bad cold; second dose fever; second dose aches; second dose chills to the bones; First dose lymph node swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ) and MUSCLE FATIGUE (third dose muscle fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cold since 16-Jul-2021 and Allergy (They are really bad). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy and Cold.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced LYMPHADENOPATHY (First dose lymph node swelling in arm). On 20-Jan-2021, the patient experienced PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches) and CHILLS (second dose chills to the bones). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (bad cold). On 27-Aug-2021, the patient experienced CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ) and PERIPHERAL SWELLING (first dose lymph node swelling in arm). At the time of the report, LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ), PERIPHERAL SWELLING (first dose lymph node swelling in arm), PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches), CHILLS (second dose chills to the bones) and NASOPHARYNGITIS (bad cold) outcome was unknown.            This case was linked to MOD-2021-300195, MOD-2021-300196 (Patient Link).
30 mins after receiving vaccine, pt. c/o "throat tightening" similar to a reaction she had after an allergy shot 5yrs ago.  States she took oral Benadryl before coming to the POD.  Received 25mg Benadryl IM at 1020.  Felt relief of throat tightening by 1030 and left with family member who was driving her.  Slept rest of day.  No further sequelae.  Reported incident to her PCP and allergist.  Is seeking guidance from them about 2nd dose.  States PCP has Pfizer vaccine in office.
Fatigue; High blood pressure; Severe cluster headache; Chills; Body aches; This is a spontaneous report from a non-contactable consumer. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included cluster headaches. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021, after first vaccine, the patient experienced fatigue, high blood pressure, severe cluster headache, chills and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, high blood pressure, severe cluster headache, chills and body aches was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On 20-SEP-2014 those patients were vaccinated with an expired dose of PNEUMOVAX 23 (lot # H010515, expiration date 13-FEB-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. Follow up information has been received from the pharmacist who stated that 66 year old female patient received expired PNEUMOVAX 23 vaccination on 21-SEP-2014. It was a visiting pharmacist that did the vaccination. This is one of several reports from the same source. Additional information has been requested.
Roughly 1 week prior to 10/26/2017 doctor visit pt experienced tenderness to abdomen no rash, then patient started experiencing numbness and tingling in groin and feet which prompted visit. After this initial visit, patient was not diagnosed with issue. Symptoms did not resolve, and continue to progress prompting a return doctor visit and eventual hospitalization. After hospitalization patient was referred neurologist 11/10/2017, patient was scheduled for an MRI 11/24/17, patient was hospitalized immediately after MRI, then diagnosed with Transverse Myelitis 11/24/2017. Patient was started on high dose steroid therapy.
Not an adverse event. It was a vaccine error.  The vaccinator accidentally got a Moderna Covid vaccine from the refrigerator instead of a Pfizer for the patient's second shot. No adverse events as of this time.
3-4 wks raised rash chest, neck & waistline area; No itch associated w/this rash; tx w/mild antihistamine;
Patient complained of left arm pain and swelling at injection site. Area was noted as warm, swollen but no redness.
she did not receive the full 0.5mL.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.    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 ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.). At the time of the report, ACCIDENTAL UNDERDOSE (she did not receive the full 0.5mL.) had resolved. Not Provided      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.   No treatment information was provided.
10-15 minutes post vax, pt was awake, appropriate oriented, but slightly slow to respond to verbal requests.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:39 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 35.65.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 15-Apr-2021, the excursion time on initial supply was 09 am, temperature was 34. Total 188 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 06-Apr-2021 and moved to clinic on 15-Apr-2021. 18 vials were moved to the clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Minor tinnitus in left ear. I received both vaccines at the same time, one in each shoulder. I am not sure which vaccine went into which shoulder and I think there is no way to tell if one vaccine or the other (or their interaction) caused the tinnitus.
This spontaneous report was received from a pharmacist refers to a unspecified patients of unknown age and gender. On 08-OCT-2014, 13 expired doses of PNEUMOVAX 23 (dose, route were not reported) (lot # H022172 and expiration date was 16-AUG-2014) was administered to unspecified patients. No adverse events were reported. This is one of the two reports from the same source. This case was linked to MARRS# 1410USA007748. Additional information has been requested.
Rt. upper arm red, swollen and warm to touch. Pt. states arm was also hard, yesterday, and had more swelling and pain at that time.
Shingles on left breast accompanied by continuous headache not much improved but acetaminophen. Preceded by 2 days of genital herpes and yeast infection. Treating with prednisolone (6,5,4,3,2,1) and ValACYclovir 1 gram 3*daily for 7 days. Outcome TBD.
Patient received her first vaccine injection and had initial symptoms of fevers, myalgia, fatigue and a local site reaction at the injection response. This lasted for 2-3 days and then improved and resolved. Approximately 10 days after vaccination, she experienced a raised acne-like, pruritic, painful rash disseminating down her bilateral thighs, pelvis and groin area. This was also associated with recurrence of a similar erythema/pain rash at her vaccination site, sore throat, and fatigue. No new exposures/allergens/contacts that the patient is aware of. Has never happened before.
pt recv vax 3NOV97 & 17NOV97 pt exp chickenpox w/approx 6 pox;18NOV97 had 17 to 19 pox;
This case was reported by a other health professional via call center representative and described the occurrence of injection site stinging in a adult female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number ZA72G, expiry date 31st May 2019) for prophylaxis. On 7th January 2019, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .1 ml. On 7th January 2019, unknown after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced wrong vaccine administered and intramuscular formulation administered by other route. On 8th January 2019, the patient experienced injection site stinging and injection site rash. On an unknown date, the outcome of the injection site stinging and injection site rash were recovering/resolving and the outcome of the wrong vaccine administered and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site stinging and injection site rash to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The medical administered a dose of FLULAVAL rather than a Tuberculosis shot to an adult female patient, which led to wrong vaccine administered. The patient received 0.1 ml dose of injected FLULAVAL subcutaneously into the left forearm, which led to intramuscular formulation administered by other route. After a day, the patient reported that the injection site burned and stung. The patient developed rash around the injection site, about 1 and a half inches in diameter. The reporter consented to follow up.
Pt received Covid 19 vaccination on 02/01/2021-SX on 02/24/2021-Positive for COVID 19 on 02/24/2021
a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a contactable nurse . A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Was notified on 04Jan2021 while the reporter scrolling on Facebook a friend of her who is a nurse who got the Pfizer COVID-19 vaccine and had side effects. Someone on had asked if the patient had any affects, patient stated a little fatigue and minor body aches. The reporter went back to and took a screenshot of the post that was dated from 23Dec2020. Patient was in her late 30's. Patient received vaccine on 23Dec2020 and she worked at Hospital name. This then triggered her to look into her other nurse friends. Apologizes for not having much information to provide on patient, she hasn't spoken to patient in 6 years. Mentioned that post only mentioned her arm was a little sore, but that was with any vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
fever with delirium including visual hallucinosis - unclear duration approximately 6 hours - unable to confirm detail was back to usual state of health following day when she awoke
At 12:20pm, the patient reports facial droop, slurred speech and left arm weakness. (covid bivalent booster received at 10:48 AM that same day). CT head completed. Other vitals WNL. Patient reports being off apixaban for at least 2 months. Patient diagnosed with acute ischemic stroke and received IV Alteplase and was transferred to another facility
Nausea; aches; tiredness; This is a spontaneous report from a contactable consumer (patient).  A 83-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) , via an unspecified route of administration on 21Jan2021 18:30 at SINGLE DOSE at left arm for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced nausea, aches, tiredness on 22Jan2021 17:30. No treatment for the events. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. 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.
Developing rashes. Rashes are small, red, and clustered. Non itchy and non painful; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 at 18:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease(Ckd) and systemic lupus erythematosus (lupus). Concomitant medications were not reported. The patient had no f known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 00:00, the patient experienced rashes and rashes were small, red, and clustered. Non itchy and non-painful. The event resulted in emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event red rash was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
administered an expired PENTACEL with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient who was administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ800AA, Expiry date: 01-Oct-2023) (with an unknown strength) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient was administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse called stating that they have administered an expired PENTACEL to a patient and wants to know our recommendation moving forward. To be specific, caller wants to know if they need to revaccinate the patient.   Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
no adverse effects; Received "VARIVAX and PROQUAD" instead of "VARIVAX and MMR II"; overdose ofthe VARIVAX vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-OCT-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/ one time, lot # S006018, expiration date reported as 20-FEB-2021, but upon internal validation established as 27-FEB-2021 (dose and route of administration were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml/ one time, lot # S008574, expiration date 16-SEP-2020 (dose and route of administration were not reported) (wrong product administered) both for prophylaxis instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # and expiration date were not reported). Other suspect therapies included and sterile diluent lot # R005478, expiration date 30-OCT-2020 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. It was reported that a medical assistant just picked up the wrong vaccine. It was additionally reported that on 22-OCT-2019, the patient received an overdose of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, as a result of the patient receiving varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccines. There was no adverse event reported.
The patient's arm quickly turned red and began to itch.  The next day she was still red and itchy, and the pharmacist then recommended Benadryl for the itchiness.
Patient was vaccinated at 5pm Thursday and woke up to swelling and a rash on his face at 8:00am Sunday
started getting a headache within an hour or so of leaving, within a few more hours started getting chills, muscle pain, fatigue, fell asleep about 4p for 4 hours, ran a low fever by about 11p. Next day still have headache (with light sensitivity), fatigue, muscle and joint pain, weakness
PT STATED THAT HER ARM BEGIN TO SWELL AND IT KEEPS GETTING BIGGER, THE SITE IS SPREADING DOWN HER ARM, IT IS RED AND HOT TO TOUCH