chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from nurse on 20 Jun 2018. This case was linked to 2018SA168277 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a third dose of ADACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event reported. 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 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.
Dizziness, off balance, pain shooting up legs into lower back none stop to point I couldn't walk. headache, dehydrated. Blood pressure was going to high.  This has been none stop since the first shot and hasn't stopped. Working with a Doctor to try and figure this out..
Patient received 3 IM injections during routine immunization visit, and shortly after 3rd injection had approx 10 second unresponsive "fainting spell", came to, but continued to feel unwell, was pale and sweaty, and complained of legs feeling "weird" and shaky.  Had patient lay on floor and EMS was called to assess patient.  After patient condition improved after approx 10 minutes, patient was cleared to leave clinic with mother.
12-2-15 4:30 pm Wife called to report that patient was in a staff meeting and he was starting to itch all over. He did not have any rash yet, but the itch seemed to be worse around the injection site. Patient has a history of severe allergic reactions to various insects and foods and has been instructed that he should call an ambulance whenever there are symptoms of a reaction. The wife was advised to go to town to give patient some BENADRYL., his epi-pens and to call an ambulance. The prescribing physician nurse was made aware of the situation. 12-4-15 10:30 am (Friday) The itching has totally resolved, but there is a local reaction that has redness about the size of a baseball and slight puffiness. The pharmacy advised the patient to call back and report the reaction on Monday and a mew Rx for epi pens were obtained. 12/3/15 - 9 am Spoke to wife - she reported that the reaction was itching in arm, head and neck no rash was seen, site of injection was red and puffy. No ambulance or hospital visit was needed. Patient had left for work and left her a note that the itching has resolved.
it burned a little; Overdose; wrong age indication; This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 13-year-old female patient who received HAV (Havrix adult) (batch number PZ353, expiry date 21st November 2020) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: A 13 year old patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The pharmacist consented to follow up.   Follow up information received from pharmacist on 2nd January 2019: The patient's demographic details were updated. On 31st October 2018, the patient received 1st dose of Havrix adult intramuscularly. The patient had no adverse event after receiving Havrix adult. This was a medication error without harm. The VAERS details were updated.   Follow up information was received from pharmacist on 20th June 2019: The patient stated that less than a year after inadvertantly receiving adult dose of Havrix it burned a little more. It was unknown if the reporter considered burning sensation was related to Havrix adult. The outcome of the event felt like burning was unknown.
This spontaneous report as received from a registered nurse refers to unspecified patients. The patient's medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL (Lot #, dose and route were not reported) that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the three patients were administered with GARDASIL (lot number and expiration date not reported). Follow up information has been received from a license practical nurse. The reporter specified the 12 year old patient was vaccinated on 13-AUG-2014 with GARDASIL (Lot # J006850, exp. date 31-MAR-2016). Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Bruise on anterolateral (R) thigh after administration of vaccine. Red and growing bump on 8/9/16.  Denies pain, itching, red streaks, fever. Pt not irritable. Eliminating and sleeping fine. On 8/10: Right anterior thigh- 3.5 cm rround macule, red, warm. Darker and mildly raised in center, lighter towards edges. Appears mildly tender to touch.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOXIA  12/21/2022 -- RECURRENCE OF SAME SYMPTOMS
onset 14JUN98 @ of joint pain in hips;since that time has had migratory arthralgias (no swelling or stiffness of joints);over 48hr from 19JUN98 has had gen myalgias & fatigue;T99.1;
Rash, 2 by 3 inches; arm red at the injection site; really itchy, 2 by 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (arm red at the injection site), INJECTION SITE PRURITUS (really itchy, 2 by 3 inches) and INJECTION SITE RASH (Rash, 2 by 3 inches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and LISINOPRIL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (arm red at the injection site) and INJECTION SITE PRURITUS (really itchy, 2 by 3 inches). On 15-Mar-2021, the patient experienced INJECTION SITE RASH (Rash, 2 by 3 inches). At the time of the report, INJECTION SITE ERYTHEMA (arm red at the injection site), INJECTION SITE PRURITUS (really itchy, 2 by 3 inches) and INJECTION SITE RASH (Rash, 2 by 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment of events was reported.
TOOK TWO DOSES IN A ROW/ WOULD BE TRAVELLING TO AN ENDEMIC AREA WITHOUT COMPLETING THE VIVOTIF COURSE; This spontaneous case (PVX2019-881) was received from a consumer on 15-Apr-2019. It describes a female consumer who "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took two doses of Vivotif on consecutive days. The doses were taken on 14-Apr-2019 and 15-Apr-2019, respectively. She would be travelling to Singapore on coming Wednesday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was unknown.  Company's Comment: The causality of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row/ would be travelling to an endemic area without completing the Vivotif course" was considered as not applicable.
Per mother child developed swelling and circular rash on arm (2 sites) on same day vaccines were administered.
Patient received Pfizer 2nd dose instead of Moderna.  Patient appears to be fine and says they feel fine.
High fever throughout night. Next day: Arm swelled at injection site, injection site swelled and next day: red rash grew from shoulder to elbow (approximately). Vomited in morning. All signs dissipated by Saturday afternoon and were gone fully by Sunday.
Reported per EUA as individual was too young to receive vaccine-First dose was given 3 wks earlier. Series completed with this dose.
Patient developed severe arm pain at the site of injection. Pain is severe enough that she is unable to abduct her arm. There is no mass, redness, warmth, or swelling at the injection site. There is severe pain wtih palpation at the injection site. MRI of the area is pending.
frequent sinus problems after a cold that started January 4, 2022 (congestion, sore throat, facial pressure)
Patient received Pfizer Bivalent vaccine in October of this 2022 and scheduled another dose today 01/04/2023. We missed the previous dose and administered a second dose of Bivalent vaccine today.
Had chicken pox vaccine 6/13/00 4/03 dx by Dr with chikenpox. Daycare called and informed.
Muscle pain; muscle soreness; Shortness of breath; Increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 23Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of Pfizer-BioNTech COVID-19 vaccine on 23Feb2021 and was originally scheduled for his second dose 23Mar2021. In 2021, the patient has been experiencing symptoms such as muscle pain, shortness of breath, and increased heart rate. Lots of muscle soreness comes. The patient asked if it was okay to take it. The patient has already rescheduled his second dose for 41 days after the first. The patient wanted to know what he should do about receiving the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Skin felt like it was on fire; Low grade fever; Chills; Arm hurt really bad; Sweating; Cough; Scratchy throat; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough) and THROAT IRRITATION (Scratchy throat) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LANSOPRAZOLE (LANSPRO) for Mood disorder, LAMOTRIGINE for Mood disorder NOS, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Thyroid disorder NOS.    On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad), HYPERHIDROSIS (Sweating) and FATIGUE (Fatigue). 21-Jan-2021, the patient experienced COUGH (Cough). 21-Jan-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 21-Jan-2021 at 3:00 PM, the patient experienced CHILLS (Chills). On 21-Jan-2021 at 6:00 PM, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire) and PYREXIA (Low grade fever). On 24-Jan-2021, PAIN IN EXTREMITY (Arm hurt really bad), SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Sweating), COUGH (Cough), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat) had resolved.        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.   Treatment information was not provided.
Fever, chills, nausea, headache, extreme body aches/pain on Saturday. Fever, chills, headache, extreme body aches/pain on Sunday & Monday. Less chills, extreme headaches, slight pain behind eyes, sore throat, congestion and cough on Tuesday. Headaches, congestion, cough, extreme pain behind eyes when looking left/right up/down, sensitive to bright lights today (Wednesday).
@1116 client reported feeling dizziness. Rapid response activated by RN.  RN,  RN and Fire Chief  responded to scene.  Client assessed to be AOx4. NAD. Head-to-toe assessment WNL. Vitals 149/93, 83, 96% RA. Based on history and chief complaint, decision made to call EMS.  called 911 @1141. Upon reassess, client reported feeling ?confused and foggy thoughts.? Noted expressive aphasia. Client reports periods of confusion being baseline after brain surgery. EMS arrived @ 1156, engine 91. Patient reports feeling better. EMS assessed client, EKG and BGL completed. Patient refused transport to hospital @1206. Since client drove to site, son was called to pick her up. Fire chief assume care of client and monitored until son picked client up and left vaccine site @1236 without incident.
patient received their first dose of Twinrix on 27-JUL-2023 and the second dose of 3-OCT-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th July 2023).   On 03-OCT-2023, the patient received the 2nd dose of Twinrix. On 03-OCT-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received their first dose of Twinrix on 27-JUL-2023 and the second dose of 3-OCT-2023).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2023 The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Patient called on 4-14-10 and stated she felt weak, dizzy, and her heart was beating very fast on 4-13-10. She stated it was hours after her pneumonia shot.
I experienced this regular flare up of pain in my left breast. It was a stabbing burning pain, every time I moved my arm or laid on my side the pain would flare up to a debilitating pain level. This went on for three weeks. The pain has now gone away.
Body aches (stomach, arms and legs, back, abdomen), chest pain, fatigue, strong headache, ear pain in both ears Not yet resolved after 1 dose of extra strength tylenol 1 hr ago
The patient came to the pharmacy requesting to receive a pneumococcal vaccine.  We administered Prevnar 13, in accordance with ACIP guidelines, because the patient is over age 65 and confirmed he had never received a pneumococcal vaccine before.  After sending the vaccine administration record to the patient's primary care provider, I received a call from nurse.  She also administered Prevnar 13 earlier that day.  The patient was supposed to ask for Shingrix, but he thought that was the one administered at his doctor's office.  I followed up with the patient and encouraged him to monitor and report adverse effects.  The patient will come in at a later date to receive the intended Shingrix vaccination.
First reaction vomiting around 2 hours later, Arm Pain swollen in injected area, fever and articular pain
Chills; This is a spontaneous report from a contactable consumer via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 40 year-old non-pregnant female patient second received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as Dose 2, single for COVID-19 immunization (40 years at the time of vaccination). It was unknown if patient had other medical history and known allergies. It was unknown if the patient had received any other medications with two weeks after Covid-19 vaccination. The patient was not Covid-19 infected prior vaccination. The vaccination facility was reported as hospital. The patient had not received any other vaccine four weeks prior to Covid-19 vaccine. The patient previously received first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. On Jan2021, the patient experienced chills which lasted only a few hours after receiving his 2nd dose. The patient was not tested for Covid-19 post vaccination. The patient had not received treatment medication for the resulted event. The outcome of the event was recovered on an unknown date in 2021.  Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Was given varicella and MMR vaccines on 06/12/13. Pt's mother brought child in on 06/28/13 stating child developed rash on 06/25/13 - seems better now. Rash is all over body - head to toe. BENADRYL given and help.
a 20 year old female presents requesting vaccination for COVID-19. Patient's identity was verified utilizing two patient identifiers. Allergies reviewed and Pt has no history of severe allergic reactions.   The patient or surrogate received EUA fact sheet and was given opportunity to ask questions: Yes Moderna COVID-19 vaccine# 1 in series administered, see Immunizations activity for vaccine details.      Immediately after receiving the vaccine pt became dizzy and lightheaded while sitting in the conference room. She was verbalizing feeling like she was "going to fall". RN STAT was called, Dr. and RN's responded to call. STAT vitals performed. Pt denied any medical conditions other than Asthma, denies taking any other medications. Pt was taken to observation area via wheelchair with o2 in place via NC 2 LPM in stable condition. Pt was able to answer questions and never lost consciousness.
Pt recv vax on 10/21/98; 1 hr later pt exp itching, red, hard, hot arm x 3 day
Headaches from the lower back of his head towards sinuses; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headaches from the lower back of his head towards sinuses) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SINUS HEADACHE (Headaches from the lower back of his head towards sinuses). At the time of the report, SINUS HEADACHE (Headaches from the lower back of his head towards sinuses) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information was not reported. The patient had a negative scan of his sinuses and received treatment for migraines. He reported that the headache is still happening on and off.   This case was linked to MOD-2021-201458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30 Jun 2021 contains non significant information
My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 11:30 (Lot number: Ew0171) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NODULE (non-serious), TENDERNESS (non-serious), SWELLING (non-serious) all with onset 18Aug2021 14:00, outcome "not recovered" and all described as "My left under arm was tender beginning Wednesday afternoon. Thursday morning, my left under arm was swollen with a noticeable knot". The event "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot", "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot" and "my left under arm was tender beginning wednesday afternoon. thursday morning, my left under arm was swollen with a noticeable knot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of nodule, tenderness, swelling.  Additional information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of drug allergy.  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
headache, burning on face, chest and ear about 2-3 min after vaccine.  Took benadryl
Patient presented to the ED on 3/21/2021, and 3/22/2021. She was admitted to the hospital on 3/23/2021 for 10 days.
In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at times severe. The first event was both knees becoming very stiff and sore. It lasted about 24 hours. A day later, both my hands became swollen and stiff. Ibuprofen seemed to alleviate the problem. Since that time, at approximately 3-4 day intervals I developed pains in hands and knees again as well as ankles, bicep muscles, wrists, and jaw. This has continued for the last 3 months, and is now only in one of the pair of joints at a time, as in just one knee, not both at the same time. My right wrist is most commonly affected.