chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 16 years old patient (gender not reported) who received a dose of vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
I have rheumatoid arthritis and after I received the vaccine, my arthritis became a lot worse. It was in my wrist and my hands and fingers were swelling up very badly. My feet and toes were swelling up as well. My feet looked rounded off. I saw a rheumatologist and the medication she gave me really helped. She gave me an injection of prednisone. She put me on Methotrexate. I used that for about 8 weeks and now I'm getting Cimzia injections because my insurance approved it. My pains became even worse after I received the second dose.
Pain/numbness in right arm starting at 630pm, still a little pain when I lift arm. Shortness of breath from 630pm-730pm, right side of face numbness/a little droopy starting around 630pm, still feels a little numb today but not bad. Severe abdominal cramp from around 815pm-915pm-took ibuprofen and that seemed to help
pt was given both varicella and proquad that has mmr and varicella. pt  family will be notified.
Patient received Tdap shot by one staff member. Right after that labs were drawn by another staff member and after labs patient was told she was ready to go but she told the second staff member she needed her Tdap. The first staff member had not completed charting the first shot and so when the second staff member saw the order for the Tdap and the patient said she had not received it yet, she also administered it.
Red large circle, warm to touch, on about 4 inch diameter. Underside of right arm not surrounding injection site.
Case number PHEH2014US010042, is an initial spontaneous report received from a nurse on 14 May 2014. This report refers to a patient of unknown age and gender. Nurse reported that a patient was administered with MENVEO (batch number: unknown) intramuscular after the Men A lyophilized component was reconstituted with a sterile diluent that was for live vaccines. No adverse event was reported. No further information was provided.
Information has been received from a physician concerning a female infant who was diagnosed with rotavirus after 2 doses of Rotateq (lot number was not available). Unspecified medical attention was sought. Subsequently the patient's immune system became severely compromised and the patient was hospitalized. Lab diagnostic studies included "serotyping the rotavirus strain." The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 75-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 26-SEP-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Very strong lower back pain. Left side just above hip; This was a booster. Initial vaccine was J&J.; This was a booster. Initial vaccine was J&J.; booster; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: FF2593, Expiration Date: was not reported), via an unspecified route of administration, administered in right arm, on 22Oct2021 at 16:30 (at the age of 64 year), as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. Historical vaccine included COVID-19 VACCINE JANSSEN (Batch/Lot number: was not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization and COVID-19 VACCINE (unknown manufacturer) as dose 2 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that bnt162b2 was a booster and initial vaccine was J&J. On the evening of 22Oct2021 at 23:00, the patient experienced very strong lower back pain (left side just above hip). The pain continued as of 26Oct2021 although not as severe it remains. The patient was not received treatment for the adverse event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
COVID 19; COVID 19; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (non-serious), outcome "unknown", described as "vaccine dose number=4". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days post vaccine I am having axillary swelling and itching.   This occurred with my first two shots and had not resolved at the time of my booster.  I received the booster in the other arm from my first two shots and now have the same swelling and pain in both underarm areas.
Contact transmission to fiance (info on fiance attached. Vaccinee had normal progression of small pox site. Fiance required emergency room / doctor visit.
In March of 2022 I woke one morning, and my left eye had hemorrhaged. I had an intense headache in the left temple. I visited my ophthalmologist. I began taking ibuprofen for swelling. Within two more days I broke out in shingles rash. The eye problem was determined to be the beginning of the shingles. My rash cleared up, but I still had the headache in left temple, and it lasted for 2 months. Just after my headache went away, I tested positive for COVID-19 on May 24, 2022. I had a mild case, and my only symptom was a mild scratchy throat. My headache in my left temple returned in November 2022 after dose 3 and 5 (Moderna) dose. The headaches were the same, lightning strike in the left temple. My eye also hemorrhaged again in November 2022 as well. I visited the ophthalmologist again and repeated the treatment as before. My headaches still continue and once they begin they can last up to one day.
with all the shots, I had something like fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (with all the shots, I had something like fatigue) in a female patient of an unknown age who received mRNA-1273 for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273  (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (with all the shots, I had something like fatigue). At the time of the report, FATIGUE (with all the shots, I had something like fatigue) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient had 2 full shots and 2 booster shots of the Moderna, and with all shots she had experienced things like fatigue.  No treatment medication was reported.
From 22nd to the 25th  sore arm at injection of Dec. 26 -27 Cough, sore through, fever,  shortness of breath and body aches then Dec. 27 COVID PCR for covid and 28 DEC the PCR positive
Red rash appeared in two different spots; upper left leg and right hip. The spots were itchy and burning. Now there are small raised bumps like blisters. Has slightly improved as of 9/18/11.
Uncommon pain and swelling at injection site several hours after injection. Pain and swelling remain plus diminished range of motion of left arm and left shoulder from time period of injection to current date. Diagnosed with shoulder impingement syndrome due to vaccine. Type of treatment includes large doses of NSAID and physical therapy for 6 weeks.
started the day of vaccination with blurred vision in left eye that went away by evening, over next 2 days including today the blurred vision continues to be intermittent severe at times then goes away
Underneath my Left Arm swelling and redness, itchy, elevated area for approximately one week after vaccine.
On December 12, 2019 My body was very weak and sick, I was Nausea, stomach pain, dizziness and stiffness in trying to walk. A weird  feeling in my head along with a severe headache, my eyes hurt in the light.  It is the worst feeling ever.  Today is January 15, 2020, and I still feel very sick on different days, I feel weak and tired  with headaches. It is hard to get around and trying to work on those days is very difficult.
screamed & cried entire noc p/vax; could not comfort; The following days noticed body curved to one side & lt arm twisted when reaching; A few weeks later dx w/infant stroke;
Information has been received from a physician concerning a 4 year old female who on 7/28/01 was vaccinated with a dose of varicella virus vaccine live. On 8/10/04, the patient presented with breakthrough chicken pox, less than fifty lesions were noted. There was no product quality complaint involved. Follow up information indicated that the patient was seen on 8/10/04 with skin lesions and was diagnosed with chicken pox. The reporter indicated that the patient's brother (WAES0409USA02580) had a similar experience following exposure to varicella virus vaccine live. No further information is available.
headache; nauseous; muscle aches; he did not sleep; This case was reported by a consumer and described the occurrence of headache in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced headache, nausea, muscle pain and insomnia. On an unknown date, the outcome of the headache, nausea, muscle pain and insomnia were unknown.   It was unknown if the reporter considered the headache, nausea, muscle pain and insomnia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and he did not sleep, was nauseous, muscle aches, and a headache. These are all side effects listed.
10 days post vax, the pt presented with erythema multiforme. No history of antibiotic usage for 6 weeks and no new detergents.
Subacute onset of bilateral cervical neck pain radiating to left shoulder with paraesthesia and sensory neuropathy including burning pain not associated with activity, not ameliorated with rest, NSAIDs or Tylenol, not worsened with movement. No associated trauma, No constitutional Symptoms.   Symptoms are most consistent with transverse myelitis
Fever, chills, body malaise. I rested and took Tylenol which have helped.
4 hours, post vax, pt began with generalized rash and hives and was very fussy and irritable. Temperature up to 100.5 at home and 101.3 (ax) in office.
Case number PHEH2014US022256 is an initial spontaneous report received from a pharmacist on 03 Nov 2014. This case refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. he was vaccinated with FLUCELVAX (batch number: 11021A), intramuscularly on 29 Oct 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
The main pain is in the base of the neck where the bones are connected to the spinal column,; On the right arm she just has soreness; the pain in the bone is on the left arm; nauseated; vomited; could not get warm; right shoulder and the right part of her neck and head where throbbing and it ached so much that; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (could not get warm), PAIN (right shoulder and the right part of her neck and head where throbbing and it ached so much that), NAUSEA (nauseated), VOMITING (vomited) and PAIN IN EXTREMITY (On the right arm she just has soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Asthma. Concomitant products included HYDROCORTISONE, CICLESONIDE, FORMOTEROL (ALVESCO COMBO), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II), MONTELUKAST SODIUM (SINGULAIR), LOSARTAN, METOPROLOL, CLONIDINE HCL, ATORVASTATIN and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (could not get warm) and PAIN (right shoulder and the right part of her neck and head where throbbing and it ached so much that). On 27-Feb-2021, the patient experienced NAUSEA (nauseated) and VOMITING (vomited). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (On the right arm she just has soreness) and ARTHRALGIA (the pain in the bone is on the left arm). On an unknown date, the patient experienced SPINAL PAIN (The main pain is in the base of the neck where the bones are connected to the spinal column,). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h; IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK, q4h; LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, NAUSEA (nauseated) and VOMITING (vomited) had resolved. At the time of the report, CHILLS (could not get warm), PAIN (right shoulder and the right part of her neck and head where throbbing and it ached so much that), PAIN IN EXTREMITY (On the right arm she just has soreness), ARTHRALGIA (the pain in the bone is on the left arm) and SPINAL PAIN (The main pain is in the base of the neck where the bones are connected to the spinal column,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications also included Immunoglobulin therapy. Patient applied heat, ice and massage to the affected area but none helped.   Patient reported that she did not want to take the second dose of vaccine.
Immediately after vaccine my face started getting hot and itching. swelling to my face and neck area  I took zyrtec for the adverse events
Inmate notified nurse at 1400 that "allergic reaction" to vaccine. Right upper arm noted to be red, blotchy, knot at injection site, warm to touch. Red blotches start mid bicep and spread up to clavicle region. Initially Benadryl 25mg give at 1400 and at 1700. Approximately 1915 patient  complained of "tongue feels funny"  report to emergency department at 1950. Recommended antihistamines for 24 hours.
Patient received Pfizer COVID vaccine lot number ER8732 on 04/19/2021 and was given the Moderna COVID vaccine as the 2nd dose on 05/11/2021.  As of today no adverse events to discuss.
about 20 hours after shot, extreme lethargy and fever of over 103 degrees (often near 104). Fever did not break until next morning, 10/04. Advil and Tylenol did not seem to bring down the fever. Only broke after a night of rest. Fever has completely exhausted my son. He is unable to go to school today.
I tested positive for COVID-19 on 12/13/22. I had congestion, vomiting, shortness of breath and headache. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I still have some congestion and shortness of breath, but I am feeling better.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 57 year old male. The patient's weight was 235 pounds, and height was 71 inches. The patient's concurrent conditions included: gastroesophageal reflux disease, high blood pressure, rare alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies or any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pantoprazole sodium sesquihydrate for gastroesophageal reflux disease, and bisoprolol fumarate/hydrochlorothiazide for high blood pressure.  On 23-SEP-2021, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000194500. The suspected product quality complaint has been confirmed to be voided based on the reported events and timelines, there was insufficient time for the patient to achieve immunity, therefore this report does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided. based on the PQC evaluation/investigation performed. This case is a duplicate of 20210946647.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Small fiber neuropathy measured by a sudoscan and a corneal confocal microscopy and a reactivation of the epstein barr virus
Altered mental state, memory loss, confusion, diagnosed as transient ischemic attack, most symptoms resolved in 24 hours
Pt received Moderna vaccine before age 18. Pt is 17 and 11 months.
High fevers, chills, myalgias, arthralgias, slight cough, headache, dizziness, loss of consciousness.
I got pregnant in July shortly after receiving the Covid vaccines. I got sick while traveling for my honeymoon that month  (I?m not sure if it was Covid). My unborn child had a rare heart defect called Truncus Arteriosis. I have not taken any medication, do not drink or smoke and am in good health. I have no one in my family history, or my husbands family history, with any know heart defects. We did further genetic testing and found that our child did not have any genetic defects such as DiGeorges syndrome. We are trying to find any correlation. The only thing I did different was get my vaccines.
ITCHING AT SITE OF INJECTION; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the subject experienced itching at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching at site of injection on 29-MAR-2021. This report was non-serious.
Date of Admission: 1/7/2022    Date of Discharge: 1/11/2022
Fatigue malaise headache nausea on March 19 all day ... fine on March 20
post-administration pt got dizzy, vision blurry, fainted momentarily.  paramedics were called, pt was screened and vital were okay.
Exactly 24 hours after vaccine I developed a severe racing heart, shortness of breath, numbness in my hands and cold/hot rushes down my neck and back. After trying to lower my heart rate at home for approx. 45 minutes, I went to the ER based on CDC recommendation as well as not having a primary caregiver. 1 1/2 hours into being there I felt my heart slow down back to normal as well as the hot/cold sensations ease up. Once my vitals became normal they released me.
Case number PHEH2012US018710, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: unknown) on unspecified date. The patient was vaccinated with only CYW-135 liquid conjugate, lyophilized A powder component was not received. No adverse event was reported.
Excursion from the freezer on 01-Oct-2021; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.