chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site was swollen; Injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy). At the time of the report, VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PRURITUS (Injection site was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
No sense of taste; Significant body aches; Significant muscle aches; Chills; Racing heart; Fatigue; Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications metoprolol (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 20Apr2021 at 22:00, the patient experienced significant body and muscle aches, chills, racing heart, fatigue and metal taste in mouth. On 23Apr2021, 3 days after vaccination, the patient experienced no sense of taste. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant body and muscle aches, chills, racing heart, fatigue, metal taste in mouth and no sense of taste was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Began with mild itching all over, and increased in severity on both arms, hands, and face, with swelling and red-raised bumps.  Eventually included torso.  Severe itching of palms.  Patient took Benadryl 50mg over the counter on 12/06/19  at 8:00 p.m., with no relief of symptoms.  Severe itching of palms decreased over a 2 day period.  Itching, bumps, and swelling continued, but did not worsen, and patient was seen by, PA-C, on 12/09/19, and was treated with ranitidine 150mg 2 times daily for 10 days, and prednisone 20mg 1 tab daily for 5 days.  Patient was also prescribed triamcinolone topical 0.1% cream, to apply to affected area two times daily.  Patient was seen again in clinic on 12/11/19, with improvement of symptoms.  Spoke with patient via telephone on 12/19/20, and patient states she has fully recovered - raised bumps, itching and swelling completely gone.
Information was received on 25-APR-2017 from a medical assistant who was reporting on a 6 month old male patient. No medical history or concomitant medications were reported. On 25-APR-2017, the patient was administered a dose of M-M-R II (lot M032153, expired 22-APR-2017, dose and injection site not reported) for prophylaxis. No adverse effects were reported. No other information was reported. Additional information has been requested.
Following vaccination resident had noted increased apin/body aches. Resident sustained a near fall on 4/13/18 in which her knees gave out from under her and she was lowered to the floor.  Following event resident had noted pain to her neck, back and shoulder.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Non-radiographic axial spondyloarthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 25Sep2023 to 28Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency response provider). Approximately 3 hours post vaccination he c/o prickly stabbing itchy pain to vaccine site with left arm pain x 24 hours. He stated day 1 post vaccination the roof of his mouth, lips felt swollen and sensitive with a random frontal dull headache that lasted for a few seconds but noted on/off for 3 min duration a few times a day.  He also reported a few days of altered sense of smell, especially to automotive products that has resolved. He states this prickly-itch stabbing pain varies all over his body, in his mouth, eyes, torso, extremities, again lasting a few seco
Shingles on right side of lower torso; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021,  04Mar2021, 14Mar2021, 22Mar2021 the patient underwent nasal swab test for COVID-19 and the result for all the test was negative. On 05Mar2021 the patient experienced shingles on right side of lower torso. 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 reported adverse event. The clinical outcome of the event shingles on right side of lower torso was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
pt recvd vax & devel fever & shrill cry for 4hrs;following 2nd vax mom noted poss enlarging of the head;seen in ER dx of scratch on eyeball was made but ER MD did not comment on enlarged head size;CT scan showed excess fluid in ventricles;
@24 hours = a sore left arm at the site of injection From 48 hours to 4 days = lymph nodes, left shoulder, left breast extraordinarily tender, mental fogginess,  and EXTREME sleepiness, which required multiple and IMMEDIATE naps throughout the day.
Headache, myalgia, n/v.  Duration about 6-10 hours
T99.8, chills, headache, fatigue on 01.31.21 at 4pm-continued through  02.01.21 until 1pm-no treatment other than rest. No s/s on 02.02.21, but then on 02.03.21 at 2pm in afternoon, became  dizzy with nausea, headache, fatigue-had to leave work, came home and slept.  On 02.04.21 still vague nausea/headache/fatigue-stayed home and  rested, took 1 ibuprofen 200mg with relief of headache. On 02.05.21 went to work, noted vague headache, dizziness, nausea-improved with 1 ibuprofen 200mg. On 02.06.21 vague headache, no treatment.
4 days low temp aches pain cough like after flu shot    Week later arm started hurting  I went to check ut out   Looked a softball  swelling at injection point   Rash was on same area    Hurt. Ice make it swell more so I took benadryl     Swell went down by the may 11 th..  Today Thursday may 13   Rash is back and bright  red  All the to about and inch from elbow     I felt over tired  f I r past two weeks.    Rash looks more like a burn  I just want to if normal   Person that answered phone at doctiex told  me  to look online.    Nothing about about how long of if rash  should be spreading   Rash are gas bern warm to touch for over a week.  Other than diarea   and fatigue  and painful arm and rash  nothing more than after flu vaccines   Can this make your jaw and teeth hurt?   Sense of taste  is way off   Will rash go away.  Will it leave scar ?  Covers whole upper arm  Is second shot really worse than the first   I was on bed for first 4 days.    Then when arm swill up  I could hardly use left arm for week    How long does rash last   Nothing helps if
dizzy; Nauseous; Burping; felt like she had been hit by a two by four in her lumbar; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727, Expiration date was unknown), via an unspecified route of administration, in left arm, on 25Mar2021 in the afternoon (at the age of 49-years-old), as second dose, single for COVID-19 immunization. The patient medical history included asthma and anaphylactic food allergies and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration, in left arm, on 04Mar2021 in the afternoon (at the age of 49-years-old), as a single dose for covid-19 immunisation. After the first dose patient had experienced dizzy, nausea and burping. Patient received 1st dose because, patient had asthma and everyone should be vaccinated. Patient wants to know if there has been reports of a similar reaction since patient had asthma. The patient did not receive any additional vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have adverse event prior to the vaccination. Patient did not have any illness at time of vaccination. Patient did not have history champion burper in the family. Patient did not perform any relevant test. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Patient History and Investigation Assessment. On 04Mar2021, after second shot about a half hour, the patient had dizzy, nauseous, and burping but the burping went on for hours. Patient got the shot in the afternoon and it went on until 8 o'clock at night and it was not one burp it was a lot of burps and patient felt like patient had been hit by a two by four in lumbar and patient had that pain for several days and stopped 2 or 3 days. Facility where the vaccine administered at the military was running it. Patient think, patient did take Advil for patients back. Adverse events didn't require visit to emergency room/physician office. The outcome of the event back pain was recovered on an unknown date in Mar2021 while rest of the events were recovered on 25Mar2021. Reporter seriousness for dizzy, Nauseous, Burping, felt like she had been hit by a two by four in her lumbar was unspecified.
PATIENT RECEIVED SECOND COVID SHOT THURSDAY 2/11/21. SYMPTOMS BEGAN FRIDAY 2/12/21: RASH, HIVES, ITCHING. PATIENT STARTED TAKING BENADRYL FRIDAY. HIVES AND RASH IMPROVED SATURDAY 2/13/21. PATIENT CALLED PHARMACY TO DOCUMENT ADVERSE EVENT 2/16/21. THIS WAS PATIENTS SECOND COVID -NO ADVERSE EVENTS WITH FIRST.
Felt like being hit by a brick; Exhausted; Fever of 100.6; Fever of 100.9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt like being hit by a brick), PYREXIA (Fever of 100.9), PYREXIA (Fever of 100.6) and FATIGUE (Exhausted) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.9). On 05-Mar-2021, the patient experienced PYREXIA (Fever of 100.6). On 07-Mar-2021, the patient experienced PAIN (Felt like being hit by a brick) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 03-Mar-2021, PYREXIA (Fever of 100.9) had resolved. On 05-Mar-2021, PYREXIA (Fever of 100.6) had resolved. On 07-Mar-2021, PAIN (Felt like being hit by a brick) had resolved. At the time of the report, FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.9 High. On 05-Mar-2021, Body temperature: 100.6 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    This case was linked to MOD-2021-036736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03/May/2021 and updated reporter contact details. On 11-Jul-2021: Follow up document received on 11/Jul/2021 and contains no new information.; 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.
1st dose: numb lips, numb left leg, and pain on left arm (site of injection) 2nd dose: vomit, nausea, rapid breathing, full body soreness, pain on left arm again, chills, and shivering
At 8:30pm felt terrible, right arm swollen, so very sore and red, rash arm down to elbow, could hardly lift it.  Had chills, went to bed at 10:30pm.  Woke up at 4:30am weak, very warm, sweating, felt like vomiting, called husband, passed out in bathroom.  Had big cut on left side of my nose, swollen.  Recovered, except bruised ribs, scar and tender by nose.
Fever and swelling at site of vaccine given 9 days earlier. Same occurrence in twin brother. Seen at outside hospital ER and discharged home. Reported by parent to provider on 9/20/16.
4 hours after vaccine of 2mo visit patient developed high pitch cry > 3 hrs. Both parents detected unusual cry inconsolable seen in ER due to that. By the time seen in ER patient was acting normal.
Swelling and redness at the vaccination site; Swelling and redness at the vaccination site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling and redness at the vaccination site) and VACCINATION SITE ERYTHEMA (Swelling and redness at the vaccination site.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling and redness at the vaccination site) and VACCINATION SITE ERYTHEMA (Swelling and redness at the vaccination site.). At the time of the report, VACCINATION SITE SWELLING (Swelling and redness at the vaccination site) and VACCINATION SITE ERYTHEMA (Swelling and redness at the vaccination site.) outcome was unknown.            No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pt initial C/O sore throat and cold sweats on 5/16/06. Pt started vomiting on Tuesday evening through Wednesday. Pt went to ER on Wed night with c/o chest pain and labored breathing. Pt was diagnosed with muscle spasms in chest due to increased swelling of lymph nodes from smallpox vaccine.
Pain in entire arm requiring pain relief, redness and swelling at injection site, lethargy, dizziness.
sore arm; she felt a headache coming on; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC taken for contraception; CALCIUM; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease; SPIRONOLACTONE taken for acne. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot EL9267), administration date: 12Feb2021, for COVID-19 immunization, reaction(s): "sore arm", "horrible headache". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "she felt a headache coming on". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: After the second dose, she felt a headache coming on she took a Tylenol and it didn't turn into a headache. She knows that the headache was common side effect with the vaccine. She tried to knock the headache back with 3 Aleve and a Tylenol. Concomitant Products included Multivitamin: (Start: Unspecified Stop: Unspecified).  No follow-up attempts are possible. No further information is expected.
Mouth, Throat and Lips started to get extremely dry and could not swallow after about 6 minutes of the vaccine, given water, helped for a minute and happened again, given more water until a nurse could come, then I was given the choice of Benedryl or Epipen. I chose benedryl, had to wait additional 30 minutes from the benedryl. Got better before I left. Very tired and sore arm the next day.
Rash started five days after injection - itching all over with red bumps that would come and go.  Has slowly improved over time - still not completely resolved as of 3/30/21
Information has been received from a Registered Nurse referring to a 5 year old male patient. ON 28-MAR-2016 at 10:09, the patient was intramuscularly vaccinated with improperly stored (Temperature: 32F-Time frame: 5 minutes) dose of VAQTA (second dose, lot # K012457, dose was unknown) in right deltoid. No adverse effect was reported. This is ne of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Tingling in fingers of arm where shot was administered; hoarseness; pain in arm. MD told pt she didn't need to go to ER or be seen unless it gets worse (verified w/ AM at MD office) called pt back at 7 pm -> said doing fine now.
No additional AE information provided; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 23-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S022755, expiration date 22-JUL-2021 (exact dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. The vaccine underwent a temperature excursion of negative 11.9 Celsius degrees for 35 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event information were provided.