chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a female patient of unknown age. On an unknown date the patient was vaccinated with three doses of GARDASIL (lot# and dose not reported). It was confirmed the product was GARDASIL and not GARDASIL9. In approximately October 2014 (reported as about four to five months ago) the patient came into the office and tests (details not specified) showed abnormal squamous cells after receiving all three GARDASIL vaccinations. No product quality complaint (PQC) was reported. The outcome of the event was unknown. Additional information has been requested.
Within 30 minutes of vax, pt developed a headache with the sensation of increased pressure in his head, burning sensation on his tongue, joint pain and muscle pain. Pt was seen in the ER and treated with antihistamines. His symptoms persisted as of 10/01/1999.
This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with her third shot of GARDASIL (lot number not provided), one week prior to the recommended third dose administration date. It was reported that this was a misuse adverse event (AE) in regarding to GARDASIL. It was unspecified if the patient had sought medical attention. Additional information is not expected.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Jul-2021. On 18-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. 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 concomitant medication was provided.No treatment details was included.
This patient accidentally received a full dose of the Moderna Vaccine at the age of 17. She received her first vaccination on 1/6/2021 and her second vaccination on 2/3/2021. This patient is also a HCP at the facility. What happened was the staff who scheduled this patient for the first dose told the patient that she was eligible to get the vaccine, so the patient assumed she was. Then she came in on her appointment day and the HCP who was giving the vaccines that day did not know that we had any HCPs under the age of 18, so she just gave her the vaccine without checking a birthdate. Then when the patient came back for her second dose, the RN who was giving vaccines that day questioned this with the patient, but the patient said that she was eligible and the RN saw that she got her first injection, so she never double checked and just gave her the second dose to finish the series. This was a mistake on both the HCPs part and they have both been talked to about this and feel terrible. The patient and her mother were both informed of the incident and they both verbalized understanding to what happened. The patient never had any adverse effects after either of the vaccinations at all and she is still feeling just fine today. No adverse events were seen or reported at all, we just caught that this patient was under the age of 18 and got Moderna and should not have.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (route and dose were not reported), lot # M001813 and expiry date: 14-OCT-2018. The vaccine was exposed to a temperature frame of -0.5 degrees centigrade for a duration of 5 hours 38 minutes. There were no previous excursions. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
After receiving the vaccine I went home. The next morning I had a fever, aches, tired, and fatigue. Those stayed for 2 days and nothing went down. The 3rd day I was so extremely tired with a fever. Then I had dark urine that was dark brown n color with blood in it. I went to the ER at Medical Center, and I was there all night from 10PM to the next morning. I was diagnosed with hemolytic anemia. I was prescribed prednisone. They asked me to stay longer in the hospital but I refused to. They told me to follow up with a hematologist. I was on prednisone for a whole week. Then I started having all these extra symptoms like joint pain, tired, and fatigue all the time. I also have nerve pain. I was referred to a rheumatologist. He said I had rheumatoid arthritis. I seen a 2nd doctor and he said I might have rheumatoid arthritis. He told me to take hydroxychloroquine. I seen a 3rd doctor and he said most of my symptoms were a sign of lupus. I have nerve pain, neuropathy, headache, extreme fatigue, and tiredness. I have been taking hydroxyzine for past 7 months, but lately the medication has been giving me ringing in my ears like tinnitus. I have stopped taking it. Recently I saw a doctor and he said I could take Mycophenolate, Azathioprine, or Benlysta instead. I never had this before the vaccine. I'm not supposed to have another dose of this vaccine.
Vaccine was stored in the freezer for 16 days, instead of 14 days. the vaccine was supposed to be removed from the freezer on 5/27 and placed in the fridge however it was not and was stored in the freezer and given to the patient.
Prevnar #4 given at 9 months old - no adverse reaction reported from parents.
arm getting sore/moves around and may be higher than ijection site/pain in left arm/Righ arm  sore all the time/Left arm pain is mild adn goes away/Pain happens when reaches up; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) and PAIN IN EXTREMITY (arm getting sore/moves around and may be higher than ijection site/pain in left arm/Righ arm  sore all the time/Left arm pain is mild adn goes away/Pain happens when reaches up) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012-M20A and 039-k204) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm sore). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm getting sore/moves around and may be higher than ijection site/pain in left arm/Righ arm  sore all the time/Left arm pain is mild adn goes away/Pain happens when reaches up). On 10-Feb-2021, PAIN IN EXTREMITY (arm sore) had resolved. At the time of the report, PAIN IN EXTREMITY (arm getting sore/moves around and may be higher than ijection site/pain in left arm/Righ arm  sore all the time/Left arm pain is mild adn goes away/Pain happens when reaches up) outcome was unknown.            Concomitant medicines include Cholesterol Medicines, Blood pressure  Medicines, Prostrate medicines  treatment medicines were not reported   This case was linked to MOD-2021-161412 (Patient Link).
Myalgia, NauseaVomiting, foggy brain, headache, tingle in arm Narrative: Employee experiencing "flu like symptoms", tired, chills, achy muscles, slight headache, foggy thinking, nausea (yesterday) , Reports her eft arms is hot, inflamed and hurts to raise above her head. Slight headache and very tired. No fever. Her symptoms started about 2 hours after the shot and got progressively worse. After work yesterday she went to bed and slept, felt better this morning but arm hurts really bad and "flu like symptoms" started again. She also reported tingling down left arm. Employee did leave work early today.
Hives over entire body treated with Benadryl for 2 days then Zyrtec.
Pt exp shrill unconsollable screaming for @ least 45min; diarrhea x 5 or 6; Fever (not measured) felt warm; lt leg red & swollen, improved late PM; APAP as directed;
Pericarditis or pleurisy. Was better after three days. Had myocarditits in 2019 and the infection timeline was identical. That one took 6 days to heal.
fell asleep when went home 1130AM woke up, screaming w/pain, held stomach, nausea then fell limp on floor; turned white, lips cyanotic; 1/2 hr p/arrival @ ER came out of it; fever 103;
Information has been received from a pharmacist concerning a patient who on approximately 20-OCT-2006 (within the last 7 to 10 days) was vaccinated with a dose of Pneumovax 23 (lot #651981/0674F).  Subsequently, the patient experienced "cellulitis symptoms".  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was noted.
Skin turned bright red and flush all over, hot felling with dizziness and seeing stars.
24 hours after receiving D/T immunization my arm at sight of injection starting hurting. I couldn't lift my arm up above shoulder level without alot of soreness and stiffness.36 hours after the injection I got a bad headache, my arm was swollen,my hand was tingling and the lymph nodes under my arm were sore and enlarged.48 hours after injection I ran a fever, had a headache, had pain in my back and chest and felt like I might need to go to the ER. After approximately 6 hours of feeling bad the symptoms subsided. I took Ibuprofen and Tylenol for pain and fever and waited it out. 68 hours after injection the sorenes and swelling have improved, but are still there and I feel very fatigued. In box 13 of this form I am not sure which D/T immunization I received.
Information has been received from a 74 year old female consumer who on 12-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, starting that evening, she had "flu" like symptoms (bad headache, fever, sore throat, muscle pain, running nose, cough, etc.). Medical attention was sought, the patient called her doctor. The doctor told the patient "let's watch it, drink more water and take good rest. If it gets worse, come to my office." The patient report she "stayed home and took good rest," after about ten days on approximately 22-NOV-2007 the symptoms were gone. Additional information has been requested.
funny taste in the mouth; kept smelling something that was not there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "funny taste in the mouth"; PAROSMIA (non-serious), outcome "unknown", described as "kept smelling something that was not there".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Date refrigerated: 20 Apr 2021  Temperature changes (in F): 42
1.  Fatigue, general weakness, headache noticed on waking approx. 15 hours after vaccine. Milder at day 2 (40 hours) but still tired. 2.  Arm muscle soreness accompanied by 2" diameter circular red mark at site of injection. Tender to touch. Slightly swollen. Noticed on second day after vaccination at approx. 40-42 hours. Was not there at 15 hours.
constipation; This is a spontaneous report received from contactable reporter(s) (Physician).  A 82 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 23Feb2021 (Lot number: EN5318) at the age of 82 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seafood/shellfish: rash" (unspecified if ongoing); "seafood/shellfish" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL EXTRA STRENGTH; NORVASC; ASPIR 81; TENORMIN; LIORESAL, start date: 21Dec2020; OS-CAL; SINEMET; LOTRISONE; VITAMIN B12 [COBAMAMIDE]; CYMBALTA, start date: 30Jul2020; CRESTOR; LASIX [FUROSEMIDE SODIUM]; MIRALAX; B COMPLEX+C; CALCIUM CARBONATE/VITAMIN D3. Past drug history included: Lisinopril, reaction(s): "Lisinopril: Cough"; Terazosin, reaction(s): "Terazosin: Trouble breathing"; Flomax, reaction(s): "Flomax: Arthralgia"; Oxybutynin, reaction(s): "Oxybutynin: SOB (shortness of breath)". Vaccination history included: Bnt162b2 (First Dose, Anatomical site of injection: Left Deltoid, Route of administration: IM, Lot/Batch number: EL9262), administration date: 26Jan2021, when the patient was 82 years old, for COVID-19 immunisation, reaction(s): "Itchy hands, legs, head, top of head and his face is itchy", "achy and hurts where got the vaccine", "he also has itching also on arm where vaccine given", "Scratch eye", "Dry skin"; Tetanus vaccination; Pneumovax vaccine.  The following information was reported: CONSTIPATION (non-serious) with onset 2021, outcome "unknown", described as "constipation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: after 2nd dose, patient states that he experienced constipation. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported.  No follow-up attempts are possible. No further information is expected.
This spontaneous case, initially received on 24-Oct-2016, was reported by a health professional and concerns an adult female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date around 20-Oct-2016, the patient received AFLURIA injection for Influenza immunisation. Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: The patient came into the pharmacy on 22-Oct-2016 and stated that in the night after the AFLURIA injection she woke and Could not hear out of left ear (Medically Significant, outcome: Unknown). Sender's Comments: Listedness: Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, unilateral deafness is unlisted. Causality: Unassessable. Time to onset is the same day of vaccine administration. However there is insufficient information such as patient age, medical history, concomitant treatment, concurrent illness, investigations into cause of deafness for causal assessment.
Mom returned to office 6/7/07 for follow OM with covering PCP noted petechiae with multi scalp/head hematoma OM unresolved. Referred to ER was hospitalized x 3 days. Bruising of body and swelling right parietal from banging of head on concrete 2 days PTA. Follow up hematologist at facility after discharge.  7/6/07 Received office notes from pcp which indicate patient seen 4/18/07 for cough & pulling at left ear. Tx for otitis media.  No office note of 5/21/07.  7/17/07 Received hospital medical records which reveal patient experienced petechial rash when seen on routine f/u exam for OM by PCP.  Sent to hospital & admitted 6/7-6/10/07.   Heme consult done.  Patient had fallen/bumped head x 2 in week prior to admit.   Tx w/IVIG.  Responded well & d/c to home w/f/u by heme & pcp.  Returned to ER on 6/10 s/p vomiting & continued petechiae.  Plts at that time were 232,000. Final ER dx: vomiting as reaction likely due to IVIG.  D/C to home w/heme & pcp f/u.    FINAL DX: Immune Thrombocytopenic Purpura.
Slight swelling at the injection site with a red, blotchy,  itchy area approximately 2 1/2" in diameter appearing {2/3/2021} exactly 1 week after my 1st covid-19 shot.  As of today, 2/4/2021  the injection site still remains red, itchy, blotchy and slightly swollen.  I am simply notifying this site of the reaction to provide you with data.
p/vax 3/2/99 woke up rt arm swollen & painful, felt achy all over, flu-like sx;off & on for a few weeks;joint pain, pain in bottom & scrotum-felt heart flutters;sx have since gone away;
Severe joint pain, fever, chills, migraine, nausea, dizziness, severe arm pain into shoulder
Vertigo. Nauseous. Fatigue. 3Days. Reaction reoccurred 10 days later.
Patient reports diarrhea, hair loss, weakness and dizziness since receiving the flu shot.
pt states had feelings of light-headedness beginning @ 230PM on 22OCT97;began noting itching on buttocks p/dinner 22OCT97;did not began to see red hives until 25OCT97;noted hives on inner arms, inner thighs, chest & trunk;
Patient is experiencing significant pain at injection site with, swelling the size of a baseball, redness, and is warm to the touch.
Red round rump below the deltoid muscle; Red round rump below the deltoid muscle; Injection was wrongly administered at the wrong muscle site; A spontaneous report  was received from a nurse, concerning a 19-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed red round lump below the deltoid muscle/ vaccination site mass and vaccination site erythema, injection was wrongly administered at the wrong muscle site/ incorrect route of product administration.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) on right arm for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination, the patient developed red round lump below the deltoid muscle and the patient's mother believed that the injection was wrongly administered at the wrong muscle site.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event red round lump below the deltoid muscle was unknown. The outcome of event injection was wrongly administered at the wrong muscle site was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # 025L20A  with  associated AEs. 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.
Given an Expired Dose of Heplisav-B; Initial Report Received on 02-Mar-2022   A registered nurse reported that a 21-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 02-Mar-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 22 Feb-2022, and NDC # 4352800301) in the left deltoid. It was unknown if the patient had any adverse side effects.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
1st dose on Feb/22, 2nd on 21/Ju/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose in February 2022).   On 21st July 2022, the patient received the 2nd dose of Engerix B adult. On 21st July 2022, unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The health care professional called to report that an adult patient received 2nd dose of Engerix B adult later than recommended interval. The reporter consented to follow-up via postal or fax. Additional supportive information: The patient received 2nd dose of Engerix B adult  later than recommended interval, which led to lengthening of vaccine schedule.
Then shot it been back 2 more times/suspected vaccination failure; It back 2 more times not as bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them once was bad).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Then shot it been back 2 more times/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It back 2 more times not as bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-Mar-2023 The case was received from the patient via interactive digital media. The patient had shot and it had been back 2 more times but not as bad. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.