chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 inch of skin around the injection site was mildly warm to touch; 1 inch of skin around the injection site is red; 1 inch of skin around the injection site is painful; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 27Apr2021 at 13:15 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included general anxiety disorder. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and prenatal vitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15 (at the age of 24-years-old) as a single dose for COVID-19 immunization. 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 vaccination. On 29Apr2021 at 12:00, the patient experienced 1 inch of skin around the injection site was red, painful and warm to touch. The clinical outcome of the events 1 inch of skin around the injection site was red, painful and warm to touch was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Admitted to Hosp on 22AUG91 because of 24 hrs hx of vomiting, diarrhea, & fever w/dec level of consciousnesss & mild dehydration; Put on electrolyte solution; vomiting ceased & fever came down; d/c on 23AUG91;
Pt recvd Rubella vax on 23OCT90; On 01NOV90 pt devel sx of URI which included a large hard, tender adenopathy in neck, boggy & bleeding nasal mucosa, t>101; 03NOV90 devel diffuse maculopapular eruption & joint pain;
Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours, the spotting increased to a light bleeding with fatigue and cramping in the abdomen and has remained this way. I am still currently bleeding. My last period ended 3/7/21. My period is never irregular.
Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 32 year old female pregnant patient non pertinent medical history who on 05-NOV-2011 ("the patient thinks") was vaccinated with her first dose of VARIVAX (Merck) (lot# not reported) at approximately 5 weeks gestation. The patient became pregnant with a LMP approximately of 05-OCT-2011 (at the time of the report the patient was approximately 19 weeks gestation) and estimated delivery date (EDD) of 11-JUL-2012. There was no concomitant medication. The patient had received the dose from an unknown facility. The patient had sought medical attention via office visiting. None treatment was given. The patient had an ultrasound on 15-FEB-2012 but this was the last time the physician would be seeing her. The patient was being referred to Obstetrics and Gynecology (OB/GYN). The pregnancy outcome was unknown. Case lost to follow up. Additional information is not expected.
Lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; administered Pentacel after temperature excursion deemed vaccines non-viable for usage with no reported AE; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 1 month old male patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) after temperature excursion deemed vaccines non-viable for usage with no reported AE (adverse event) and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine (hepatitis B vaccine) for Prophylactic vaccination.  On 13-Feb-2023, the patient received a dose of suspect diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Suspension for injection) lot UJ671AA (expiry date: 15-Mar-2023) via intramuscular route in the right vastus lateralis for immunization (strength: unknown).  On an unknown date lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product storage error) (latency-same day).  On 13-Feb-2023, the patient was administered pentacel after temperature excursion deemed vaccines non-viable for usage with no reported ae (poor quality product administered) (unknown latency).  Action taken: not applicable  Outcome was Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 15-Feb-2023- Patient age, new event (lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product temperature excursion issue) and event onset date were added. Text amended accordingly.; Sender's Comments:  01493844   : 01493845:
Redness of arm 10.5 x 6.75 inches - from R UZ
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 070H21A, 043B21A and 027C21A) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy, Allergy to nuts (tree nut) and Food allergy (Wheat). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 patients received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21-Oct2021 and administered on 24-Aug-2022). No concomitant drug information was provided. Patient never been diagnosed with or tested positive for COVID-19. Patient did not have any acute illnesses at the time of vaccination. It was reported that the expired vial was placed in refrigerator on 21-Oct-2021 and was clearly labelled not to use as the vaccine  which was expired. The vaccine continued to remain in the refrigerator until it was taken out of the refrigerator and administered to patients. The vial hadn't undergone any temperature excursion issue.  As per Moderna CMC Lot analysis, regarding dose(s) administered on 24-Aug-2022: Moderna cannot guarantee patients received full protection against the COVID-19 Virus No treatment drug information was provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Live Follow-up has been received in which Reporter information and Narrative  were  updated. On 25-Aug-2022: Live Follow-up has been received, Suspect drug information and I narrative was updated.
Information has been received from a physician assistant concerning a 69 or 70 year old female who in October 2007, was vaccinated SC with a dose of zoster vaccine  live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified) given in "the other arm". Subsequently in October 2007 the patient experienced a rash at the injection site that went down her arm. Unspecified medical attention was sought. The physician assistant described the rash as "looking like a severe case of cellulitis". There was no product quality complaint involved. The patient's outcome was not reported. No further information was provided. Additional information has been requested.
ACHES; BACK ACHE; NECK ACHE; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.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. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced aches, back ache, neck ache, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, headache, fatigue, back ache, and neck ache. This report was non-serious.
1/18/15: Presented to Urgent Care Center with complaints of left leg limp and pain (same limb as vaccination). Parent states the symptoms began 1/17/15.  Pneumovax had been given in left thigh at PCP office on 1/16/15.
2 weeks post vax, the pt experienced extreme muscle pain in left deltoid area, after a few days the pain radiated in to the right deltoid area and began experiencing extreme fatigue.
Recd vax between 10AM & 11AM; Tylenol given q4hrs; PT slept most day & night; 9AUG91 woke mom appr 830AM; PT's rt leg & lt arm were jerking, lt side of face was twitching & drooling; taken to ER; dx'd as sz due to ear infection aggr by vax;
Patient states she was experiencing  loss of consciousness for few seconds and mild nausea and vomiting.
Received 1st dose of Moderna on 2/24/2021 and little to no reaction. Received 2nd dose of Moderna on 3/23/2021 @ 2:30pm. On 3/24/2021 patient experienced what is described as an out of body experience. He felt extreme fatigue and his muscles wouldn't move. He said they felt cramped up. This went on from 9:00am until 3:00pm on 3/24/2021.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 4:09 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received booster dose of Moderna COVID-19 vaccine  The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg exp date of 04-Apr-2022  No treatment medication was reported.   This case was linked to MOD-2022-542869 (Patient Link).
backache; depression got worse; depression worse; don't feel good; Headache; sore left arm; achy all over; mild fever; tiredness; Swelling in lymph nodes on both sides; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (backache), DEPRESSION (depression got worse), CONDITION AGGRAVATED (depression worse), FEELING ABNORMAL (don't feel good) and LYMPHADENOPATHY (Swelling in lymph nodes on both sides) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (right breast surgery). Concurrent medical conditions included Depression. Concomitant products included LISINOPRIL for Blood pressure high, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, CALCIUM, COLECALCIFEROL (CALCIUM AND VIT D) for Osteoporosis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CELECOXIB (ZOBREX), MONTELUKAST SODIUM (SINGULAIR) and MACROGOL 3350 (MIRALAX) 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 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (Swelling in lymph nodes on both sides). On an unknown date, the patient experienced BACK PAIN (backache), DEPRESSION (depression got worse), CONDITION AGGRAVATED (depression worse), FEELING ABNORMAL (don't feel good), HEADACHE (Headache), VACCINATION SITE PAIN (sore left arm), MYALGIA (achy all over), PYREXIA (mild fever) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at a dose of 1 dosage form. At the time of the report, BACK PAIN (backache), FEELING ABNORMAL (don't feel good), VACCINATION SITE PAIN (sore left arm), MYALGIA (achy all over) and PYREXIA (mild fever) outcome was unknown, DEPRESSION (depression got worse), CONDITION AGGRAVATED (depression worse) and FATIGUE (tiredness) had not resolved, LYMPHADENOPATHY (Swelling in lymph nodes on both sides) had resolved and HEADACHE (Headache) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-049893 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Added con meds, added treatment medication, added event On 10-May-2021: Follow-up information received on 10-May-2021 contains no significant information
Per caller patient has had no adverse side effects; Phlebotomist reporting that an expired dose of MMR-11 ( expired 6/17/2021) was accidently administered to a patient on 6/18/2021.; Information has been received from a phlebotomist, referring to a 33 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-JUN-2021, the patient was accidentally vaccinated with an expire dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S018594, expiration date on 17-JUN-2021 (administration route and anatomical location were not provided) for prophylaxis. Per caller patient has had no adverse side effects.
got the newer vaccine and got it/suspected vaccination failure; It got in eye; It got in eye, nose, scalp, mouth, ear, and left side of the face; like a painful death; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles and it was worse than labor pains for all 3 of the kids), measles (had measles) and mumps (had mumps). Previously administered products included Zostavax (they came out with the first vaccine, it was learned that it was not effective and it was only one dose). Family history included chickenpox (patient's 3 kids got the mild cases of chickenpox when they were in their teen).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the newer vaccine and got it/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: It got in eye) (serious criteria GSK medically significant), shingles (Verbatim: It got in eye, nose, scalp, mouth, ear, and left side of the face) and pain (Verbatim: like a painful death). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that they said the patient get shingles if he or she have had chicken pox. Not true, the patient never had chicken pox in his or her whole life which was verified by his or her mother. But still at that point, the patient did not get the chicken pox.  The physicians recommended the patient get the vaccine 6 months later and when they came out with the first vaccine, it was learned that the vaccine was not effective and it was only one dose.  So the patient got the newer vaccine which required 2 doses at different intervals and got in his or her eye, nose, scalp, mouth and ear. The patient stated that it was like a painful death and it was only contained on the left side of his or face. This case was considered as suspected vaccination failure since the details regarding the 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.
Information has been received from a consumer regarding her mother with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced a growth underneath her eye.  The dermatologist said it was a benign tissue, and it was surgically removed.  Subsequently, the patient recovered.  There was no product quality complaint involved.  No further information is available.
NON-RAISED RASH ABOVE LEFT KNEE; ITCHING ON ARMS AND LEGS; DRY MOUTH; This spontaneous report received from a patient concerned a 64 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included: bursitis, and concurrent conditions included: allergy to antibiotics, environmental allergies, and drug allergy with lidocaine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, expiry: Unknown) dose was not reported (dose number in series 1), 01 in total, administered on 07-APR-2021 at 13:00 hours on left deltoid for prophylactic vaccination.  On 07-APR-2021, within 15 minutes of vaccination, the patient had redness of face, and fever (dose number in series 1). It subsided within the next 15 minutes. On 08-APR-2021, in the evening, 24 hours after vaccination, the patient had bursitis type irritation (dose number in series 1) which didn't last very long. The patient also had headache in the back of the head on the right side on the base of the skull and felt like pulsating pain (dose number in series 1). The headache subsided within next 20 minutes. As per patient, she had Bursitis in the past and the vaccine seemed to trigger it, hence she contacted doctor's office at that time. The patient recovered from bursitis type irritation on an unspecified date, redness of face and fever on 07-APR-2021, and headache in the back of the head on the right side on the base of the skull and felt like pulsating pain on 08-APR-2021 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, expiry: Unknown) dose was not reported (dose number in series 2), 01 in total, administered on 30-DEC-2021 at right deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for environmental allergy.  On 31-DEC-2021, the patient experienced itching on arms and legs (dose number in series 2) in the middle of the night and it had continued till the morning of reporting, without a rash. On 01-JAN-2022 (in the morning), the patient had some pink dots/ non-raised rash above her knee on the left side (dose number in series 2). According to the patient, it might had happened due to itching. The patient reported that she did not have dry mouth in past. At the time of reporting patient's mouth was dry and she felt thirsty (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arms and legs, and dry mouth, and the outcome of non-raised rash above left knee was not reported (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220100909 (Dose number in series 1).
generalized not feeling well that afternoon following immunization.  Began to run a fever - Tylenol taken.  by 6:00pm, hives emerged on her chest, arms, back. Face very red.  Then dizziness and difficulty breathing by 9:00pm.  Taken to Urgent Care and was examined by nurse practitioner.  Benedryl 50 mg given po
DTaP #5 given in Rt arm 8/20/02. Rt arm red and swollen at site on 8/21/02. Advised to use ice packs and Advil. Keflex susporsian 1tsp tid x 1 wk given on 8/22/02.
pt developed fever after 1st shot. pt fainted after 2nd dose. -3rd shot not given. Note due to our recall system, I phoned pt mom to let her know about Hep B. Thats when mom declined telling me her rxc after 1 & 2.