chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to an adult Asplenic patient of unknown age and gender. No other relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PEDVAXHIB (lot#, expiration date, dose and route were not reported) (inappropriate schedule of drug administration). Additional information has been requested.
Mother of patient called pm triage nurse at 4:29am 10/29/02; Barcklay had temp 104, crying and not consolable. Came back to our office 10/29/02 at 1:30pm, was sent for CBC and blood culture, results came back without S/S infection.
Patient felt some tightening in throat area, but no difficult breathing. Over the next 24 hours, the tightening continued and patient completely lost voice (even whispering was difficult). No other symptoms of cold or illness noted (no fever, sore throat, congestion, runny nose, body aches, fatigue, etc). This symptoms slowly started to resolve on 10/16, and patient is about 80% recovered today 10/19.
my armpit to left breast is tender and swollen; intermittent pain under left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:30 (Lot number: EW0179) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, Prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, Prev dose lot unknown=True,, prev dose lot unknown reason=Unable to locate or read the details,, prev dose number=1,, prev dose vaccine location=Left arm), when the patient was 46 years old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset 08Oct2021 15:00, outcome "not recovered", described as "my armpit to left breast is tender and swollen"; PAIN (non-serious) with onset 08Oct2021 15:00, outcome "not recovered", described as "intermittent pain under left breast". Therapeutic measures were not taken as a result of swelling, pain.  Additional Information: Patient did not take other vaccine in four weeks. Patient did not take other medication in two weeks.Patient did not receive any treatment for AE. Patient did not have covid prior to vaccination. Patient did not tested covid post vaccination. No known allergies are reported.  No follow-up attempts are possible. No further information is expected.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 treatment: Ginger (To fight COVID) in 2020 and Zinc (To fight COVID) in 2020. Past adverse reactions to the above products included No adverse event with Ginger and Zinc.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not provided.  It was reported that in 2020 before there was a treatment for COVID patient had used zinc and ginger to fight COVID and it worked and kept it away. Then he had took the Moderna COVID vaccine. Now he could not find a way to get rid of it. It grewand kept replicating. He thought he was okay after vaccine but maybe it was still there.  Treatment medications were not provided.
Case number PHEH2016US028530, is an initial spontaneous report received from a consumer on 28 Oct 2016. This report refers to an infant male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) on an unknown date in Oct 2016 and booster dose was administered 2 weeks off label use on 28 Oct 2016. No adverse event was reported following this medication error.
Initial information received on 28-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age unknown) who experienced autism, while she received vaccine  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious autism (autism spectrum disorder) (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. case details: patients mother reported that my daughter got the DTap vaccine and now she has autism. (Other relevant tests included no lab data.) Final diagnosis was autism. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for autism. List of documents held by sender: none.; Sender's Comments: This case concerns a female patient who presented with autism spectrum disorder after vaccination with DAPTACEL. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
About 15 minutes after DTaP/Hib, MMR, father called to say child had redness around mouth and redness on abdomen and in diaper area. Nothing at site of injection. By the time child returned to office, no redness of face, mild erythema of abdomen. No urticaria. Gave single dose of Benadryl.
Severe headache, lightheaded, low BP, feeling woozy, dizzy, halo around all lights, light sensitivity, general weakness, heavy eyes, itchy eyes, exhausted, difficulty concentrating, metal taste in mouth - have felt this way on and off since 30 minutes after getting the shot
Red  at the injection site; welt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red  at the injection site) and INJECTION SITE SWELLING (welt at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, ANTIHISTAMINES and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE SWELLING (welt at injection site). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red  at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Red  at the injection site) and INJECTION SITE SWELLING (welt at injection site) outcome was unknown.            This case was linked to MOD-2021-015139, MOD-2021-015139 (Patient Link).
Per pt - she noticed getting sharp pains in her right chest about 20-30 min after getting flu vaccine. She said she did not report this because she was experienced this at other times. She then got a scratchy throat, itchy chest & wheezing. She obtained some relief with her albuterol inhaler & BENADRYL. Today she is c/o general body malaise. See provider not for additional
Red rash began 9 days after receiving the vaccine. Rash was the size of a 50 cent piece. Located below the injection site. Patient stated rash now extends to her elbow. It is about 2-3 inches wide. It is red, warm to touch. Denies blistering or swelling. States it is very itchy and some what sensitive to touch.
cardiovascular problems; diagnosed with Guillain-Barre syndrome/suffered paralysis from her waist to her toes/suffered permanent nerve damage/gait issues; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 15-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered paralysis from her waist to her toes. The pt was diagnosed with Guillain-Barre syndrome and had suffered permanent nerve damage. In addition to gait issues, the pt had also suffered cardiovascular problems. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events of Guillain-Barre syndrome and cardiovascular disorder to be related to zoster vaccine live (ZOSTAVAX) (reported as all of these injuries were caused by zoster vaccine live (ZOSTAVAX)).  The events of Guillain-Barre syndrome and cardiovascular disorder were considered to be disabling. Upon internal review, the event of Guillain-Barre syndrome was determined to be medically significant.
Patient received moderna vaccine on 8/12/21 and 9/9/21. Presented to ER on 6/17/22 and found to be covid positive. presented to the emergency department complaining of weakness and dizziness.  She is living at home alone since her husband was placed in nursing home and having difficulties with self-care.  Workup in the emergency room sewed positivity for COVID so she was admitted.  Supportive care was initiated.  Found via workup to also have urinary tract infection.  Was started with physical therapy and occupational therapy and was felt she would benefit from continued rehab and nursing home setting.  Case Management consulted and this was facilitated.  Was discharged to local care Home on the above date in stable condition.  Was not short of breath or hypoxic during her hospitalization. Discharged on 6/21/22
Shingles herpes zoster virus. Had shingles. Dr. sent letter for me to take vaccine ZOSTAVAX, CPT code 90736. Took vaccine on 12-17-07, has not heal yet.
shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose  of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318,  via an unspecified route of administration in the right arm on  08Feb2021 at 11:45 (at the age of 78-years-old)  as a SINGLE DOSE for Covid-19 Vaccination.  Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies.   Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit.  No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
This spontaneous report as received from a male patient of unknown age reporting on himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAR-2016, the patient was vaccinated with ZOSTAVAX (refrigerated vial 19400 PFU) (strength, lot#, dose#, dosage and route unspecified). The patient reported that he had experienced following adverse events after receiving the ZOSTAVAX vaccine: redness, an unspecified rash and swelling around the injection site and down to the elbow; heat, itchiness and warmth where the redness was; the glands under the armpit hurt. The outcome of the events was unknown. Product quality complaint (PQC) was not involved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy ZOSTAVAX. Additional information is not expected as reporter's contact details was not provided.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/24/2022 &  11/10/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt exp pain, swelling, & redness of the arm of inject p/receiving Td; Seen in ER on 7JUN91 & was treated w/DPH;
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 Lot Number S43277, Expiry Date 30Sep2019, intramuscular on 02Oct2017 15:00 at 0.5ml, intramuscularly, in Deltoid Left for immunisation. The patient medical history was none. No additional vaccines were administered on same date. The patient's concomitant medications were not reported. The patient experienced whole arm hurt and it was hard to lift from 02Oct2017 15:15 which was assessed as medically significant as per the reporter with outcome of not recovered. The patient was not seen by a physician regarding this. The pharmacist does not feel that it was the fault of the medication, but believed that it was administered improperly, either too high or too low. Sender's Comments: Whole arm hurt and hard to lift on the vaccinated limb are more likely associated with the wrongly administered site resulting from the improper technique in vaccination process; in the meantime, vaccination site pain and limb mobility decreased are the known adverse event risk for the suspect vaccine.
administered ACTHIB to a patient wherein the diluent is expired by one day with no reported adverse event; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case via other health professional.  This case involves a 16-month-old female patient who was administered ACTHIB to a patient wherein the diluent is expired by one day with no reported adverse event after receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP).  On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine (batch lot number: UJ637AA) (strength, form: unknown) (expiry date: 27-Feb-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of administered ACTHIB to a patient wherein the diluent is expired by one day with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: 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 guidelines. 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.
Pt devel hives, mom called clinic pt broke out in hives Sunday AM itching; Taken to ER given DPH;
From telephone contact received from reporting physician stated that a male patient received a JE-VAX vaccination on 06/18/01. That same day the patient developed a local reaction of 10 cm of redness at the injection, swelling and itching. These symptoms reportedly resolved. From additional correspondence received on 12/04/01, additional vaccine,  patient and responsible physician information was provided. This case is closed
I noticed at noon that his left thigh had a 3 inch round red lump that was raised. It was hot to the touch with a lump in the center. He didn't seem to be bothered by it at all. He didn't have a fever, it kept growing in size so I contacted his pediatrician. The pediatrician informed me that this reaction is common after the vaccine and to ice it and it should go away in a matter of days or weeks. It went away in 24 hours there is only a faint pink color and its not as warm to the touch. The lump as well has gone down.
This vaccinee with no symptoms of connective tissue disease prior to vaccination, developed systemic lupus erythematous, after receiving influenza, MMR, typhoid, meningococcal, tetanus and diptheria and oral polio vaccine. She had not received any drugs known to induce SLE prior to vaccination. Treatment included corticosteroids, cyclophosphamide, hydroxychloroquine and azathiprine. She continued to experience residual symptoms for up to 7 years of follow-up.
Painful injection, escalated pain, inability to move arm - tenderness to touch - improves with rest and escalates if attempts to use arm again. Pain meds used, moist heat. MRI planned for future.
Headache, Fever, CHILLS, ABDOMINAL CRAMPING, FATIGUE Narrative:
103 fever, headache, horrible body aches, fatigue.  Side effects lasting almost one week so far. Unable to function and complete daily activities for 4-5 days.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. 3 administrations on 22 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.  This case was for the 17th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
pt described malaise, stiffness in neck & shoulder w/pain approx 3 hrs; p/inject erythema & induration approx fifty cent size @ site of inj; aporx 24 hrs post inj; tx w/analgesics & ice pack locally;
chills so bad I can't stand it; fatigue; Headache; Joint pain; Nausea; Vomiting; I was not good; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good). At the time of the report, CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended