chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; first dose was given 10SEP2022 and the second dose second dose given on 2OCT2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given 10SEP2022 and the second dose second dose given on 2OCT2022) and NO ADVERSE EVENT (No Adverse Event) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis.     It was unknown  if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 10-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Oct-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 02-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given 10SEP2022 and the second dose second dose given on 2OCT2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given 10SEP2022 and the second dose second dose given on 2OCT2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given 10SEP2022 and the second dose second dose given on 2OCT2022).    Concomitant medication list was not provided. Treatment information was not provided.
Client verbalized feeling light headed after receiving the vaccine  Client stated, "I passed out, but this is normal for me after receiving any shots or seeing blood."  Client refused medical evaluation from Fire Rescue.  Client was educated on the importance of a full evaluation by rescue.  Client exit location at 12:20pm.
what to do moving forward after they have administered expired MENACTRA with no reported adverse event; Initial information received on 01-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced what to do moving forward after they have administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine [Menactra] (batch lot : U6921AA,Expiry date : 17-Apr-2022) (unknown strength, formulation) via unknown route in unknown administration site for immunization.  On 20-May-2022 (latency :same day) the patient developed a non-serious event of  what to do moving forward after they have administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event .  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.
developed sx of stuffy nose, congestion- tested positive on Abbott ID now molecular test- has had 1 dose of Janssen, no booster
2 inch diameter area of erythema to left thigh; no warmth, no s/s of infection;
left otitis; First dose on 16-Aug-2022 and second dose on 22-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (left otitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Aug-2022 and second dose on 22-Sep-2022) in a 10-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     Patient was never diagnosed with/ tested positive for COVID-19. Patient had no chronic long-standing health conditions.  Concomitant products included HIB VACCINE CONJ (TET TOX) (ACT HIB) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for an unknown indication.   On 16-Aug-2022 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 22-Sep-2022 at 3:56 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 22-Sep-2022 at 3:56 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Aug-2022 and second dose on 22-Sep-2022). On 18-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR INFECTION (left otitis). On 26-Jan-2023, EAR INFECTION (left otitis) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Aug-2022 and second dose on 22-Sep-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received Bivalent dose on 07-Feb-2023 at 08:29 am. Dose number 3, route intramuscular, site left thigh, dose 0.2ml, batch number 215K22A. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event were reported as none.  Treatment medication was not reported.   This case was linked to MOD-2023-713289 (Patient Link).
This morning after the child received the vaccines his right arm was swollen and red and fever was 104 hr. He was taken to Pediatric Clinic. No treatment. MD advised Motrin and cool compresses to arm. If arm worsened he was to be taken to the hosp. The next day the swelling and fever were much improved.
On 12/26/20 I had chase pain I felt like I was going to have a gerd attack, my blood pressure was all over the place sometimes it will be high other times it would be low, I felt like I was going to break a sweat but never got a fever, under my chin & under my armpit I had swollen it was tender to the touch. On 12/30/2020 I seen my doctor and I was also feeling better.
hives at injection site and swollen lymph nodes under left arm; hives resolved after benadryl; vaccine site was warm/red
01/13: same day had staff having chill, fever 99.4, fatigue, headache.  Friday 01/15; bodyache, headache, no fever.  Sat resolved. Now back to work.
Egg sized redness surrounding the injection sit, which is hot and hard and rough. 5 days after vaccination it is no better. This is the first time combined vaccine given. He usually gets separated shots (polio and DTaP as separate shots instead of Kinrix combined shot).
February 5th, Intense hives and itching and Swollen lips. Went to the ER. Was administered Diphenylhydramine twice, Epinephrine, famotidine, and Methylpred.  Feb 6th, Same symptoms. Went back to ER. Was administered diphenhydramine, famotidine, and methylpred again.  Feb 7th, Same Symptoms- face now also swollen and puffy. Was administered dexamethasone, diphenhydramine, famotidine. Feb 8th, Same Symptoms- hives spread to lower body and upper body, burning feeling. Went back to the ER. Was administered dexamethasone, diphenhydramine, epinephrine, famotidine.
SHARP SHOOTING PAINS IN MY LEFT SHOULDER/BACK AREA, TRIED MASSAGING AREA, GOT WORSE THROUGHOUT THE NIGHT AND FROM THEN ON.
On 10/29/2001 Pt received Flu vaccine at approximately 1200. Pt has received flu immunization for many years without incident. Approximately 18 hours post flu vaccine pt has fever. Approximately 24 hours post vaccination pt becomes dizzy and has difficulty walking. Weakness progresses but pt waits until following week to see neurologist. At that office visit pt received Solu-Medrol infusion followed by 1 week of oral prednisone. Exacerbation of MS lasted in totality about 2.5 weeks and did not resolve until completion of oral prednisone. Pt's spouse decided that her husband should not receive the flu shot in the future.
From faxed correspondence received on 7/22/02, it was reported: This case is in follow up to report(s) previously submitted on 7/21/02. Information has been received regarding a case in litigation concerning a female child who was vaccinated with a second and third dose of hepatitis B vaccine recombinant on 10/25/99, and 4/19/00. Concomitant therapy included a dose of varicella virus vaccine live on 2/9/00, MMR vaccine live (second generation on 2/9/00), a dose of Streptococcus pneumonia vaccine on 4/19/00; a first, second, third and fourth dose of hemophilus B conjugate vaccine on 4/7/99, 5/21/99, 7/15/99, and 4/19/00; a first dose of hepatitis B vaccine on 7/15/99; a first, second, and third diphtheria toxoid/pertussis vaccine/teta on 4/7/99, 5/21/99 and 7/15/99; a first and second dose of poliovirus vaccine on 4/7/99 and 5/21/99. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. This is an amended report. The fill numbers have been added for hepatitis B vaccine recombinant. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events (OMIC). No further information is available. This report is corrected as amended. Follow up on 5/22/03: New version to update the medical assessment. Case is closed.
Patient received MMR + Varivax on 8/13/08-as documented by nurse, MMR in left arm, VARIVAX in right. Presents today (8/20) with 1 week hx intermittent redness (R) arm-pruritic-2x3 cm patch erythema anterior upper (L) arm with few pinpoint vesicles in center. dx contact dermatitis (poison ivy) vs vaccine reaction-but rxn not at injection site or even arm that VARIVAX was given.
Pt vax /w DTP/OPV given vaccine in the PM had 2 probable seizures that evening (mumbling, generalized trembling, could not squeeze with rt arm or fingers.
I experienced serious sharp penetrating arthritic type pain in the tricep areas of both arms this morning in which I have never experienced before. It remained there most of the day and around 3-4 pm the exact type of pain left those areas and went directly to my left hip area.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. Concomitant products included acyclovir and trazodone. On 12th January 2018, the patient received the 1st dose of SHINGRIX. On 12th January 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling unwell. On 15th January 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter reported this case for herself. The patient received thyroid medication concomitantly. Before noon of the 12th January 2018, the patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient experienced mild flu like symptoms for 3 days. The patient claimed that she did not felt well. The patient claims that the lot number was either 9VC39 or 9XC39. However, from sales data sheet, the correct batch number was considered as 9XC39.
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21.   I continued to feel these symptoms with lessening severity over the next 3 days until Sunday  2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
Pt reported lightheadedness and could not see (could not see at all). Pupils became dilated. Pt stated within a few minutes that items in his field of vision began to look purple and shortly after he could tell me how many fingers I was holding up and could follow my finger. Pt was sweaty and gave him an ice pack to cool him down. Pt was ok and said he felt normal and fine within 20 minutes. Told guardian to monitor him throughout the night and if anything comes up to take him to the emergency department. Guardian stated she would f/u with his guardian regardless.
Atypical febrile seizure. 12/8/2009 DC summary for 10/3-10/5/2009, patient with 1 week hx of fever, also runny nose and loose stools, had new onset seizure activity with tonic-clonic movements, cyanosis and lethargy. LP done, IV ABX
Myositis.  Began to have muscle pain on 10/18 and dark urine on 10/21/21.  Urinalysis consistent with myoglobinuria.  Other labs pending.
02/11/22 I woke up with a sty and it was painful and I used warm compress for a few days but it got worse. I went to see ophthalmologist and they put me on an eye ointment azithromycin and I started that on the 16th. On the 19th I started doxycycline and eye drops on 03/01/22. It took 3 months to go away.
Two weeks approximately after last Covid shot on May 26, 2021 PT began to experience small undefined seizures which resulted in a tonic clonic seizure beginning on July 16, 2021 resulting in hospitalization a return to inpatient hospitalization again the next week with continued seizures uncontrolled through medication. To hospital stays for now defined Epilepsy was not present prior Covid shots.
bone aches in general, all the body; Has no appetite; armpits hurt; chills; feels exhausted; has had fever of 100.1; lots of headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone aches in general, all the body), DECREASED APPETITE (Has no appetite), AXILLARY PAIN (armpits hurt), HEADACHE (lots of headache) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prostate cancer stage IV, Lymphoma (Two lymphoma at base of her hip) and Gastritis. Concomitant products included OMEPRAZOLE for Gastritis, ABIRATERONE ACETATE (ZYTIGA) and PREDNISONE for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced HEADACHE (lots of headache). On 22-Mar-2021, the patient experienced BONE PAIN (bone aches in general, all the body), DECREASED APPETITE (Has no appetite), AXILLARY PAIN (armpits hurt), CHILLS (chills), FATIGUE (feels exhausted) and PYREXIA (has had fever of 100.1). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg one pill. At the time of the report, BONE PAIN (bone aches in general, all the body), DECREASED APPETITE (Has no appetite), AXILLARY PAIN (armpits hurt), HEADACHE (lots of headache), CHILLS (chills), FATIGUE (feels exhausted) and PYREXIA (has had fever of 100.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 100.1 f (High) 100.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mouth lesion on interior of lip appeared 12-24 hours post shot, very swollen bottom lip and painful
Coughing spells; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Sep2021 (at the age of 43 year) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Sep2021, consumer stated that she did not have chills but had coughing spells. Consumer would like to know if she can still get COVID even after being vaccinated and if the cough just might be from the vaccine. The outcome of events was not recovered.
Headache, Myalgia, Arthralgia, Fever, SkinRash, Rash, UrticariaPruritus, Purpura, NauseaVomiting, flare up tendonitis, fatigue,  Narrative:
This case was reported by a pharmacist and described the occurrence of pneumonia in a 69-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date in early September 2010 the subject received 1st dose of ENGERIX B (20 mcg, unknown, left arm). On an unspecified date in September 2010, 2 to 3 days after vaccination with ENGERIX B, the subject experienced pneumonia. On unspecified dates that same month the subject experienced phlegm and possible chronic obstructive pulmonary disease (COPD). The subject had three chest x-rays that showed the pneumonia was clearing, but the subject still has a lot of phlegm in the chest. It was reported that the treating physician thought the subject also had COPD. The subject was initially treated with a seven day Z pak and was later prescribed 150mg LEVAQUIN daily for 14 days because the symptoms continued. This case was assessed as medically serious by GSK. At the time of reporting the pneumonia, phlegm and COPD were unresolved.
This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to a patient of unknown age. On 29-MAY-2013 the patient was vaccinated with an expired dose of M-M-R II (lot number 0597AA, expiration date 26-APR-2013) (dose not reported, subcutaneous). Concomitant therapy was not reported. No adverse effect was noted. Additional information has been requested.
Swelling in arm pit.   Pain at injection site Pain in arm pit Redness at injection site Firmness at injection site
Narrative:  PATIENT PASSED FROM COVID-19 ON 06/02/2022. PT WAS FULLY VACCINATED FOR COVID
Yesterday 12/28/02 some local pain. Today, 12/29/02 itchy, redness, swelling noted. Vaccinated for MMR, DTaP, IPV, Hep A on 12/27/02.
SWELLING OF THE LYMPH NODE ON THE RIGHT SIDE OF NECK; 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced swelling of the lymph node on the right side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the lymph node on the right side of neck. This report was non-serious.
Patient received an expired dose; Administered a 2nd dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number PX27G, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix  (received 1st dose on an unknown date).   On 2nd February 2023, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and extra dose administered. On an unknown date, the outcome of the expired vaccine used and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Feb-2023 and 6-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Kinrix in right arm after expiration date in order to complete the Dtap-ipv series, which led to expired vaccine used and extra dose administered.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 6 month old patient of unknown gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 23-JUL-2018, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot number R00646 with expiration date on 24-OCT-2019, for prophylaxis (dose, route of administration, and anatomical site were not reported). The reporter specified that no adverse effects were present.
During 11/26/18 Well visit patient was given a Tdap instead of PEDIARIX. Vaccine error has been reported to the Health Dept. via VAERS thru records system. Voice report has been made as well. I have also spoken with health dept & patient will need to have the PEDIARIX repeated again. Patient has appointment for 12/27/18 for 2nd flu shot & will give Pediarix at that time. Health dept said that would be great timing. Thank you.
Red, swollen, warm at sight. Had noticed the day after. It was hot the afternoon of the injection - Seen 5/26 diagnosed cellulitis; to start KEFLEX
Sixteen hours after the vaccine I awoke in Atrial Fibrillation. My doctor said it was "possible" that I went back into AFIB due to my bodies reaction to the vaccine. Up until this point in time my AFIB was being controlled by medicine after one Heart Ablation for the past two and one-half years. He changed my medicine from Flecainide Acetate to Propafenone and when that didn't revert me to normal rhythm he scheduled me for a second ablation which took place four weeks later. I was in AFIB the whole time which wasn't normal for me. 90 days after the 2nd Ablation he took me off of Propafenone. Now I'm only on Eliquis for the AFIB condition. Heart is in normal rhythm.
LEFT SIDED NECK PAIN; LEFT ARM SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 12-APR-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 APR-2021, the subject experienced left sided neck pain. On APR-2021, the subject experienced left arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm sore and left sided neck pain was not reported. This report was non-serious.