chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose not given in allowed time window; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time window) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time window) outcome was unknown.        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 relevant concomitant medication was reported. Treatment information was not provided.
getting hives randomly; big red blotches on her arm, neck, and foot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (getting hives randomly) and RASH MACULAR (big red blotches on her arm, neck, and foot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Allergy to plants. Concomitant products included LORATADINE for Allergy, OMEPRAZOLE for Heartburn.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA (getting hives randomly) and RASH MACULAR (big red blotches on her arm, neck, and foot). At the time of the report, URTICARIA (getting hives randomly) had resolved and RASH MACULAR (big red blotches on her arm, neck, and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has been getting hives randomly after getting the vaccine. She has gotten big red blotches on her arm, neck, and foot. When she rubbed her arm against a cardboard box, she got a hive on that spot.The hives last about 20 minutes.   Treatment medication was not provided.
Patient memory and state of mind was very strong. After the shots, she went from 100% strong to about 75%, then 50%, and now she can't remember things 5-10 minutes.
Case number PHHY2011US56426 is an initial spontaneous report received from a nurse on 24 Jun 2011. This report refers to an 18 years old male patient. He was given only the MenCYW liquid conjugate component of MENVEO (batch number X10051) without being reconstituted with MenA lyophilised conjugate component, intramuscularly on 22 Jun 2011. No other adverse reaction was reported.
On 12/29/00, mom reports 104F (R) temperature. Child cranky and with all over body rash. Pt seen by MD that day for illness. MD noted measles rash on cheeks, lower extremities and soles of feet. Rash blanches; bilateral inguinal nodes and anterior cervical adenopathy. CBC done which showed right shift consistent with viral illness.
Patient experienced a generalized seizure lasting at least two minutes on Jan. 14th, having received the vaccine on Jan. 6th.  Patient has no history of seizure disorder.  Patient was taken to the ER per his physician's order.  CT scan, x-ray and blood work were unremarkable except for an elevated whilte blood cell count.  Patient was released and convalesced at home. There has been no further seizure activity. Patient did not recieve the second dose of the COVID19 vaccine.
Redness, cellulitis. Counseled to use cold compress, antihistamine if not allergic (benadryl allergy on file).
Narrative:  swollen face and lips,was classified as angioedema like by medical provider. Reason for Call : Reported that she went to the ER for reaction to flu shot Spoke With : Patient Follow-Up Needed : Was given prescription for benadryl and pepcid. Will order benadryl 25mg every 6 hours as needed,and pepcid 20mg daily to be sent overnight. Patient denied being sent home from the ER with any medication. Was given prescriptions only. Advised to get medications OTC today. If condition gets worse to go back to the ER. Will see patient 9/27/18. Patient stated she verbally understood.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On21-AUG-2015,  the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). The specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature excursion. The storage criteria was refrigerator (R).  The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 224, 31 and R respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
it was rpt fr HCP concerning a pt who was vax in 1995 & in 1999 pt exp breakthrough varicella w/approx 300 lesions noted. addl info requested
ABOUT SIX HRS AFTER HAVING THE SHOT MY ARM BECAME VERY SORE ABOUT THE SITE. LATER THAT EVENING MY ARM WAS SO SORE THAT I COULDN'T LIFT IT OR USE IT.  THE UNDERSIDE OF MY ARM BECAME VERY RED, SWOLLEN, HOT AND EXCRUCIATINGLY PAINFUL TO THE TOUCH.  IT LOOKED LIKE CELLULITIS.  TODAY, 4 DAYS AFTER THE SHOT, THE REDNESS AND SORENESS IS SUBSIDING.
sick; can't stand up by himself; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EM9810) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Arthritis" notes: Verbatim: Arthritis; "Cirrhosis liver" (unspecified if ongoing), notes: Verbatim: Cirrhosis liver; "pain" (unspecified if ongoing); "He got Corona Virus and he got through that." (unspecified if ongoing); "he had fluid in the stomach" (unspecified if ongoing); "he had ammonia in his brain" (unspecified if ongoing); "he couldn't talk or speak" (unspecified if ongoing); "About two or three days after surgery he couldn't speak" (unspecified if ongoing); "He could use the walker to go to the bathroom by himself." (unspecified if ongoing). Concomitant medication(s) included: RIFAXIMIN; SPIRONOLACTONE; FUROSEMIDE; SERTRALINE; ENULOSE; FAMOTIDINE; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; NOVOLOG taken for diabetes mellitus; LANTUS taken for diabetes mellitus; LIDOCAINE; VOLTAREN [DICLOFENAC SODIUM] taken for arthritis, pain; DICLOFENAC SODIUM; OXYCODON.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "dizziness"; ASTHENIA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "weakness"; DYSSTASIA (non-serious), outcome "unknown", described as "can't stand up by himself".  Additional information: Patient got dizziness and weakness 3 days after the vaccine and it is ongoing.  Patient was scheduled to receive second dose of vaccine on 15Mar2021. He took Oxycodone about 20 years. He had to give up Oxycodone because his liver is not working right now. He tries not to take Oxycodone.  No follow-up attempts are possible. No further information is expected.
High Fever around 102 degrees, Headache, severe pain along spine and base of skull, weakness, glassy eyes, general aches all over.
[PfizerProduct name] use for COVID-19 under Emergency Use Authorization (EUA): Patient received first dose of Pfizer vaccine 04/17/21 [Lot EW0171] in left arm and began experiencing numbness/tingling from the next day until now. Patient received 2nd dose of Pfizer vaccine in right arm [Lot EW0183]] with no ADRS. She was prescribed gabapentin 100mg nightly (5/17) initially then 300mg and still not responding. Is being referred for Neurology.
Sore Throat, Skin Tightness and Hypersensitivity, Chills, nausea, body aches, muscle pains, fatigue, injection site soreness
Wednesday - 3/3/2021 2:00 AM - chills, fever and nausea 4:00 AM - passed out, duration unknown 6:00 AM- chills and fever until 6:00 PM
MEDICATION ERROR; INCORRECT STORAGE OF THE DRUG; EXPIRED VACCINE ADMINISTERED; THE UNPUNCTURED VIAL WAS LEFT OUT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.No concomitant medications were reported. On an unspecified date, the subject experienced medication error, incorrect storage of the drug, expired vaccine administered, and the unpunctured vial was left out at room temperature for more than 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error, incorrect storage of the drug, expired vaccine administered and the unpunctured vial was left out at room temperature for more than 2 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459605 and 20210459605.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown.  There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 14Jan2021 at 09:00 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included heart disease and high blood pressure (HBP). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included acetylsalicylic acid, clopidogrel (PLAVIX PLUS). Other concomitant medications included unspecified blood pressure medication, unspecified cholesterol medication, and unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, diarrhea, headache, and elevated temperature on 15Jan2021 at 14:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included body temperature: elevated on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of body ache, diarrhea, headache, and elevated temperature was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
kicked my ass; fever; headache; strength of a wet noodle; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 30 years ago on face and it was incredibly painful). Previously administered products included Shingles vaccine with an associated reaction of fatigue (received on an unknown date and experienced fatigue, refer case US2021AMR200694) and Pneumonia vaccine with an associated reaction of fatigue (received on an unknown date and experienced fatigue, refer case US2021AMR200694).   In September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a day after receiving Shingles vaccine, the patient experienced fever, headache, strength loss of and fatigue. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, headache and strength loss of were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fever, headache, strength loss of and fatigue 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 got the second shingle shot 2 days ago and this one made patient tired. The patient had fever, headache and strength of a wet noodle for 2 days.  The patient hoped that it kept from getting Shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200694:same reporter
felt a little tired; scalp and left side of my face still numb; scalp still itches in the evenings; This case was reported by a consumer via  interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tiredness, numbness and itchy scalp. On an unknown date, the outcome of the tiredness was unknown and the outcome of the numbness and itchy scalp were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, numbness and itchy scalp to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient just received 2nd shot of Shingles vaccine. On next day, the patient felt a little tired but beats getting it again. The patient's scalp and left side of face still numb and scalp still itches in the evenings. Note: The event itchy scalp and numbness were conservatively captured as events, as it was not clear if their events occurred before or after vaccination.
dry taste in his mouth; metallic taste in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth). On 03-Feb-2021, TASTE DISORDER (dry taste in his mouth) and DYSGEUSIA (metallic taste in his mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.   No treatment information was reported.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL 9 was not reported. This is one of six reports received from the same source. Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA014396: US-009507513-1712USA013057.
14 year old patient incorrectly received Pfizer 5-11 year old formulation on 11/20/2021 for her first dose. Guardian was counseled and patient received Pfizer 12+ formulation for her second dose on 12/11/2021.
Ringing in the ears. Started the day after the 1st dose. Ranges from high pitch sound to a constant buzzing sound.
Fatigue; Injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Jan2021 15:00 (Lot number: EN5318) 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: FATIGUE (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "Injection site soreness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain. Additional information:Comments/Narrative: There was no error, only that I received my 2nd dose approx., 10 months after my first, that is all. No follow-up attempts are possible. No further information is expected.
A female patient (weight: probably 160 pound) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0150) at single dose via an unknown route in left upper arm on 11Apr2021 for Covid-19 immunization. Medical history was not provided. Concomitant drugs included on occasion melatonin, ascorbic acid (VITAMIN C), and vitamin D. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) on 21Mar2021 for Covid-19 immunization and experienced left arm was numb all the way down to hand was not working and nervous.  Patient went to doctor every year having basic lab work done but none other than that. Since gotten vaccinated she had left arm numbness, to the point that she got up on 25Apr2021 morning and left arm was numb all the way down to hand was not working and it made her nervous enough given her age that she was having another issue. So, she went to the hospital.  It started with her first vaccine dose. She was always been very healthy and this all started pretty much when got vaccination.  She went into the emergency room on 25Apr2021 morning because when woke up entire arm and hand was totally numb. Like she could not move hand. It was like a claw. The reason of hospitalization patient stated that she thought she was having the stroke. She walked into the emergency room and they treated with they had me in the room and headed to the CAT scan within 10 min. Patient was discharge on 25Apr2021. Patient's brain and heart were ok but she still had a numb arm. She also sated that she didn't have a concern. Treatment taken in response to adverse events included paracetamol (TYLENOL). Outcome of the events was unknown.  Follow up needed, further information has been requested.
Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 011L20A) for COVID-19 vaccination.     It was reported that the patient did not have any Acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Drug allergy (Sulfa).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022).    Concomitant medication was not provided.  It was reported that there were no other potential causes.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-554190 (Patient Link).
hurt more; little bumps on legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE (at the age of 60-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced immediate allergy. On an unspecified date, the patient experienced hurt more, little bumps on legs. The patient questioned whether she can be put on Benadryl. The patient received second dose on 27May2021. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
12 hours after my second shot I started feeling exhauasted, then I got a headache and the chills. I had the chills for a while then got a fever. It hovered around 101 fever for a full 24 hours. I had body aches and generally just felt like I had the flu for a day. Then my fever broke and my body was less sore right around 24 hours later. I'm just extra tired now.