chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported from 23-JUL-2021 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 18-AUG-2021, the patient experienced body aches. On 18-AUG-2021, the patient experienced nausea. On 18-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with risankizumab was withdrawn. The patient recovered from body aches, nausea, and headache on 20-AUG-2021. This report was non-serious.
Alkaline Phosphatase Level 269/Alkaline Phosphatase Level 444; Started feeling bad, feeling not like herself/Felt like something was inside pushing or kneading for a couple of weeks; Abnormal Mammogram; Abnormal CT Scan; Abnormal PET Scan; Doctors saying it looks like cancer; Looks like lungs are collapsing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunization at a hospital. Medical history included breast cancer from an unknown date and not ongoing recovered after radiation 6 years ago. There were no concomitant medications. No additional vaccines administered on the same day. No vaccinations within four weeks prior to the first administration date, states she does not normally get vaccines. The patient previously received the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunization. On an unspecified date in 2021 after the last vaccination, the patient was having a lot of tests now and the doctors saying it looks like cancer, one of her test looked like her lungs were collapsing, she started feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks, had abnormal mammogram, abnormal CT scan, and abnormal PET scan. The patient's alkaline phosphatase level was 71 on Oct2020, 269 on 13May2021, and then 444 on 07Jul2021 and her doctor was concerned about these results. The events required physician's office visit for consultation. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 71 on Oct2020, blood alkaline phosphatase: 269 on 13May2021, blood alkaline phosphatase: 444 on 07Jul2021, computerised tomogram: abnormal on 2021, test: lung were collapsing   on 2021, mammogram: normal on Jan2021 nothing was wrong, mammogram: abnormal on 2021, positron emission tomogram: abnormal on 2021. The patient has a biopsy scheduled for next week on her breast and lungs. The outcome of the event feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks was not recovered while for the rest of the events was unknown.   Information on the lot/batch number has been requested.
normal side effect, having fever and nausea, 8 hours after the vaccine; normal side effect, having fever and nausea, 8 hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine). At the time of the report, PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Patient received PREVNAR 13 on 11/17/2016. Patient states that injection "hurt" when going in. On 11/19/16, noticed rash on upper part of arm-warm to touch-no itch on 11/21/16. Rash moved below injection site-not painful.
Four days after the vaccine was administered, patient saw a round rash (1.5 inch in diameter) which was warm to the touch. Patient is also experiencing lethargy.
Swollen armpit of the arm that the injection was received- swollen lymph node with pain.
Patient experienced syncope. She didn't feel well, turned pale and felt dizzy and faint. She sat in a chair for awhile and also laid on the floor. She was fine after about 20 minutes or so.
Woke up this AM and couldn't move.  Is able to walk short distances, like to the bathroom.  Has pain in all muscles and bones.  Better this afternoon.
a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine; a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine; it is very, very tiny on the bottle; injury; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 23-month-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose number unknown, 0.2 ml single (Lot number: FP7135, Expiration Date: 30Nov2022) at the age of 23 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 24Jun2022, outcome "unknown" and all described as "a 23 month old child was inadvertently administered 0.2 mL of the Pfizer Covid vaccine gray cap adult vaccine"; INJECTION SITE INJURY (non-serious) with onset 24Jun2022, outcome "unknown", described as "injury"; PRODUCT USE COMPLAINT (non-serious) with onset 24Jun2022, outcome "unknown", described as "it is very, very tiny on the bottle".  Additional information: It was reported that she called to advice that they have administered an adult dose grey cap Pfizer COVID-19 Vaccine to 23 months old baby. They have given 0.2 ml of the dose to the patient. She told that she handed the vaccine to the provider and it was checked by the provider but it was the provider who administered the COVID-19 Vaccine and also reported that he grabbed the needle as reporter stuck his leg, the dad didn't have his arms and when he grabbed it when the needle came out, it scratched his leg a little bit. So, but reporter didn't inject anything he grabbed it as soon as reporter stuck in reporter didn't get to put the plunger down. So, he got stuck again with the wrong and had the injury. Reporter grabbed the needle out of his hand and reporter just stuck him again, the provider was holding his legs down.
c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date
redness at the injection site; "Need to itch hard"; Swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard"). On 01-Feb-2021, VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and PRURITUS ("Need to itch hard") 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.   Patient consumes other medication: for diabetes, blood pressure and cholesterol. Patient put ice on vaccination site. Treatment medications were not provided.
Myalgia, flu-like symptoms Narrative: Per nursing report: "Called to report had 2nd dose of Moderna yesterday [3/31] due to not feeling well this morning. C/o feeling slowed down with achingness and feeling flu-like symptoms."
Soreness and tenderness the next day. Then  developed a raised circular welt that was hot and itchy. This occurred day after vaccine and lasted 2days. Re-occurred with severe itchiness on 3/4/21. Not sore just raised, red and itchy.
Expired vaccine was administered to patient. vaccine expired 4/4/22 and was administered 4/5/22
Tinnitus symptoms began 1 day after first dose of the vaccine.  Never had this before the vaccine.  Sounds like mosquitos buzzing in the background.  very soft at first but is getting a bit louder now; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the arm left on 27Feb2021 at 10:30(at the age of 68-years-old) and received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:  EP7534) via an unspecified route of administration in the arm left on 20Mar2021 at 10:15(at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included colon cancer and gastric bypass. Concomitant medications included vitamin supplements(unspecified). The patient previously took oxycodone, paracetamol(PERCOCET) from unknown date to an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Mar2021, the patient experienced tinnitus. The patient reported that the tinnitus symptoms began 1 day after first dose of the vaccine. She never had this before the vaccine and it sounded like mosquitos buzzing in the background. The sound was very soft at first but was getting a bit louder at the time of report. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling of upper arm with erythema extending to upper 3rd of left arm with itching. (Local reaction). No fever.
Patient felt dizzy and    light headed. Gave the    patient some snacks and    water and she felt better    later.
This spontaneous report as received from a physician via company representative refers to a 77 year old female patient with allergy to "NSAIDs". The patient had no pertinent medical history. On 25-NOV-2009 the patient was vaccinated with ZOSTAVAX (one shot, 0.65 ml, subcutaneous; lot number unknown). Concomitant medication included "nothing immunosuppressive". On September 2013 the patient developed a "severe Case of shingles with post-herpetic neuralgia" after having received ZOSTAVAX. (It was verified with the field representative that the physician stated that this patient developed post-herpetic neuralgia even though the onset date was verified to be last month). The patient sought medical attention and received treatment. No lab diagnostics studies were performed. The outcome of the events was unknown. Additional information has been requested.
Pt reported lump at injection site on 01/22 (pt received vaccine on 01/21).  According to pt, size of lump grew over time and is about 2/3 size of baseball.  Advised pt to seek medical attention and speak to pt's doctor.
Bell's palsy -L side of face began 1/30/2021. Gradual onset.  Began with dysarthria and droop of corner of mouth, then upper brow of eye, then weakness in closing L eye.  Went to Hospital ER.  Diagnosis made after exam and tests
Booster end of January and that is when dizziness. Allergic reaction and covered in hives, throat closure.  Treated with benadryl.
pt recvd vax & devel erythema, pain, swelling & induration measuring 1 1/2 inches @ the site of inject;
vaccine worse than having shingles/suspected vaccination failure; shingles/have had those suckers twice; 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.   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: vaccine worse than having shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/have had those suckers twice). 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: 28-Mar-2023 The case was received froe patient via interactive digital media. The patient did not need to ask his or her physician. The patient have had those suckers twice and that vaccine was way worse than having shingles. 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.
Email received to the  inbox on 22SEP2023 at with a healthcare professional (HCP) AE report from the Merck Manuals Info mailbox. Verbatim: "We had a patient receive the Varicella vaccine post-partum. Instead of it being mixed wit; Wrong product administered; This spontaneous report was received from a Pharmacist and referred to a female patient of age. The patient's concurrent conditions, medical history, Concomitant therapies and historical drugs were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); Instead of it being mixed with the diluent it was mixed with sterile diluent it was mixed with epoetin alfa epbx (RETACRIT) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) (Wrong product administered, Product preparation issue).
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.            No concomitant medication information provided. No treatment medication information provided. The causality of event COVID-19 with Moderna vaccine was possible while the causality of event COVID-19 with Rinvoq was not reported.  Company comment: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine (unspecified date of vaccination). Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine (unspecified date of vaccination). Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
red circle around injection site; warmth at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle around injection site) and VACCINATION SITE WARMTH (warmth at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included HYDROCHLOROTHIAZIDE, ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITE), ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, PRAVASTATIN, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site) and VACCINATION SITE WARMTH (warmth at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red circle around injection site) and VACCINATION SITE WARMTH (warmth at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Bioflexin and a stool softener, not otherwise specified. No treatment details reported.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001851 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (second out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked to cases no. US-BN-2022-001839, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
Vertigo presented 3 weeks after vaccination and lasted 3 days - treated symptomatically.
Pt was diagnosed with shingles in ED on 8/14/21. The patient received his first COVID vaccine on 9/3/21 after lesions had healed. He was seen again in ED 9/16/21 and diagnosed with a recurrence of shingles.
Pt received Covid vaccine BUD. Vaccine expired on 10/13/22 and was given to pt on 11/01/22
Extreme muscle pain in thighs and calves for continuing for 20 hours with no let up. I used heating pad and drank 10 bottles of water no food. High temp and coughing until blood appeared. 07/29/2012 all pain and cough were gone completely. The muscle pain was not on the hand out the doctor issued me. Should be added to the reaction list for this vaccine.
PO 96, HR 98, dizzy,BP 118/68 PT LEFT AREA THEN RETURNED...  Wife driving home
From 3-8-22 and continuing; fatigue gradually increased, body aches gradually increased, joint stiffness gradually increased, weak muscles gradually weakened, hair feels oddly different, brittle nails, occasional nausea, transient headaches, skin pressure sensitivity
2 wks p/vax start limping, (lt leg); 4 wks stiff in both hips, legs, feet @ times would not stand or crawl; abdo pains, as well as swelling in hands & arm joints @ ten to 12 wks; heat like rash over body;
Patient received / a dose of Bexsero that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA13CA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported On 29th March 2021 patient received Bexsero which was expired on 28th February 2021. The reporter did not consent to follow up.