chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse (who was also an office manager) refers to a 55 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-SEP-2016, the patient was vaccinated intramuscularly with 1 ml dose of RECOMBIVAX HB (lot # M011838, expiry date 09-AUG-2018). Concomitant medications were not reported. On 28-SEP-2016, the patient had pain in the right arm during movement and she called the office to report that. No treatment was given. The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Syncopal episode immediately following immunizations. Pt recovered within 10 min. F/u 2 hours later - pt. WNL.
on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke,  aneurysm
upper lip is swollen; prickly feeling; inflammation to the pre-existing areas of eczema on her arms and neck; arm pain at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, eczema, hypothyroidism, anxiety and anaphylaxis (after beta blocker). Concomitant products included clonazepam and levothyroxine sodium (Synthroid).   On 21st March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 24th March 2022, the patient experienced pricking skin sensation and inflammation localized. On 25th March 2022, the patient experienced lip swelling. The patient was treated with benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site swelling was recovered/resolved and the outcome of the pricking skin sensation and lip swelling were not recovered/not resolved and the outcome of the inflammation localized was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, pricking skin sensation, inflammation localized and lip swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's comment: The patient self reported the case. On the day of Shingrix dose, the patient had arm pain and swelling at the injection site. On 24th March 2022 at 8pm, 3 days after Shingrix dose,the patient developed a prickly feeling and further described this feeling as inflammation to the pre-existing areas of eczema on arms and neck. On the day of reporting, 4 days after Shingrix administration, half of her upper lip was swollen. The injection site pain had decreased over the past four days and was mild now. She treated the prickly feeling and lip swelling with oral Benadryl. On the day of reporting patient was having appointment with her doctor.  The reporter consented to follow up with physician but declined to provide doctor's name or contact information at this time as she wanted to speak with him first. The reporter consented to follow up by email but declined to provide email.
Went to ER due to pain in the body the week of thanksgiving, ER ran test and said he had arthralgia.
Patient has gastric cancer that was in remission.  Within 48 hours of receiving the vaccine he noted abdominal discomfort and swelling which progressively increased and led to a diagnosis of malignant ascites within a week of the vaccine.
anaphylaxis; long time acute arm and shoulders pain; long time acute arm and shoulders pain; spleen and liver pain; spleen and liver pain; recurrent swallowing bumps on chest and neck; Recurrent rashes on face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "long time acute arm and shoulders pain"; ABDOMINAL PAIN (non-serious), HEPATIC PAIN (non-serious), outcome "unknown" and all described as "spleen and liver pain"; SKIN DISORDER (non-serious), outcome "unknown", described as "recurrent swallowing bumps on chest and neck"; RASH (non-serious), outcome "unknown", described as "Recurrent rashes on face".Please explain why this spike protein stay so long in body and destroy organs. What the had to do recover faster and improve my status que.  The lot number for bnt162b2 was not provided and will be requested during follow up.
LOCALIZED PAIN IN LEFT DELTOID AREA WHICH STARTED ABOUT 2 HOURS AFTER VACCINE AND HAS NOT IMPROVED SINCE.
This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced caller states they still have aches and pains, fever, chills/shivers  on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: fever on unspecified date day and a half. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212266 same reporter/drug, different patients.
Left upper arm above elbow red, firm, slightly tender swelling. Benadryl po.
having trouble breathing; When gave first vaccine in right arm, the opposite arm (left) was completely numb; When gave first vaccine in right arm, the opposite arm (left) was ice cold; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (having trouble breathing) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced DYSPNOEA (having trouble breathing) (seriousness criterion medically significant), HYPOAESTHESIA (When gave first vaccine in right arm, the opposite arm (left) was completely numb) and PERIPHERAL COLDNESS (When gave first vaccine in right arm, the opposite arm (left) was ice cold). On 05-Jan-2022, DYSPNOEA (having trouble breathing), HYPOAESTHESIA (When gave first vaccine in right arm, the opposite arm (left) was completely numb) and PERIPHERAL COLDNESS (When gave first vaccine in right arm, the opposite arm (left) was ice cold) 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.   Reporter reported that patient came to get the second dose of the Moderna COVID-19 vaccine. Post first dose patient developed numbness, coldness on the left arm and breathing difficulty .The event started within couple of minutes and got recovered within couple of hours. . First dose lot number and expiration date not available. No concomitant medications were reported. The patient refused the treatment.  Company comment: This Spontaneous case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Dyspnoea. The event occurred immediately after receiving the first dose of mRNA-1273 vaccine. The event required emergency medical assistance, however the patient declined treatment. The patient recovered within a couple hours. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Dyspnoea. The event occurred immediately after receiving the first dose of mRNA-1273 vaccine. The event required emergency medical assistance, however the patient declined treatment. The patient recovered within a couple hours. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient did not have an immediate reaction. About an hour later she had swelling around the injection site and closing of the throat.
Fever, chills, and throbbing head pain  on the left side of head. Light headed and very pale. He could not move or head will be throbbing and very painful.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Elevated blood pressure-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Hypertension-Medium, Additional Details: Patient felt syncope 10 minutes after vaccine administration. We gave bottle of water, orange juice and apple juice. Patient felt slightly better but felt dizzy upon standing. Took blood pressure 196/109 plus 90. Called 911. Patient alert and responsive/talking the whole time.
Patient was by mistake administered with Covid-19 Moderna Booster Only (Monovalent) instead of Covid- 19 Updated Booster (Bivalent).
PT EXPERIENCED ERYTHEMA AND EDEMA AT SOI SUBSEQUENT TO ADMINISTRATION OF TYPHOID VACCNE, USP, DRIED, ACETONE INACTIVATED
- Significant pain in arm vaccine was injected (L arm) around 15 min after gave vaccine. - Administered ice pack with ibuprofen & ORAPRED patient. - No swelling or redness. - Called patient 4 hrs later & pain was reduced, no other symptoms.
had the COVID vaccine and has had COVID; had the COVID vaccine and has had COVID; This spontaneous report from a contactable consumer reporting under the same suspect product(s) for 13 patients. This is 9 of 13 reports.   A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a 20-year-old girl who had the COVID vaccine and has had COVID and the side effects from the COVID vaccine are the same side effects get from COVID. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever 2 days after vaccination, rash, red cracked bleeding lips, bright red feet and hands, swollen hands and feet, blood shot eyes, crying.  Fever lasted 6 days was hospitalized and treated for Kawasaki's disease with ivig and asprin.  9/14/09 Hospital Records /  Infectious Disease Consultation Report Received DOS 7/24/09 to 7/27/09. Assessment: Kawaski's Disease. 6 days prior to admission fussy, fever. Right otitis media. Erythematous maculopapular rash on back spreading to anterior trunk, arms, legs, face. Eyes red, watery, yellow discharge. Lips turned red, hands feet swollen. Nasal congestion, rhinorrhea, cough. decreased appetite, increased brownish green stools. Urethral meatus erythema.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 13-AUG-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
MENACTRA was expired and administered to a patient, with no reported adverse event; Initial information was received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17- years old male patient who experienced menactra was expired and administered to a patient, with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  This case involves a 17 years old male patient who received an expired  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 22-Sep-2021, the patient received a 0.5 mL dose of suspect MENACTRA (lot number: U6690AA and expiration date: 23-Aug-2021) via intramuscular route in the arm for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "What do we need to do next office manager asking if there is any grace period. Reporter was not sure if the patient had MENACTRA in the past or not. That was a new patient to them. Office manager stated that the patient may have gotten the flu vaccine as well that day, but she was not sure."  At the time of reporting, no adverse event was reported.  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.
She says she has lost some weight; bad headache and it was almost a migraine; bad headache and it was almost a migraine; she didn't feel good to her stomach she felt kind of sick; she didn't feel good to her stomach she felt kind of sick; The 2nd dose created a very fast heartbeat in her; Her blood pressure was low; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168), via an unspecified route of administration, administered in Arm Left on 07May2021 (age at the vaccination 65-year-old) as single dose for COVID-19 Immunization. Medical history included myocardial infarction and heart surgery from Aug2019 to unknown date. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EW0169) on 16Apr2021 for COVID-19 Immunization and experienced COVID-19 Immunization. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that the 2nd dose created a very fast heartbeat in her and she just wanted to let Pfizer know that. Her blood pressure was low, but her heartrate went up and it was higher than what it should have been on 08May2021. She is alright now, but it lasted for a good 12 hours. Patient says she has lost some weight. She got the COVID vaccine at 1500 on Friday 07May2021 and she woke up about 0300 AM on Saturday, 08May2021, with her heart racing and she called the COVID nurse that day and the nurse said to keep an eye on it and to make sure that it did not go higher because if it did go higher than the caller would need to go to the emergency room. It eventually went down but it was high for quite a while. She had every single one and then the heart racing. She did not feel good for about 3 days. Probed for specific side effects, start dates and stop dates and caller says that she does not remember when they all started but she had a headache all day that lasted until the third day, it was a bad headache and it was almost a migraine. Also, she did not feel good to her stomach, she felt kind of sick. There was a lot that she had, it was about 10 on there that she experienced but most of them went away after about a couple days. Patient did not visit emergency room and physician office. The outcome of the event blood pressure low and heartbeats increased was recovered on an unspecified date in 2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected.
to ER with SOB,   had covid and was  ADMITTED ON 10-30-2022 and required intubation.  had h/o addisons disease on chronic hydrocortison, Had resp failure.  paroxysmal afib,   had bacteremia due to enterococcus faecium.  Had covid pneumonia . remdesivir from 10-31 to 11-3;  had linzeolid ,   had zosyn as well.   consults with pulmonology, neurology, dietician, psychiatritry, cardiology, nephrology, infectious disease, hospice referral made for home hospice, general surgery for PEG tube ,  Eventually was able to be dc to home apparently on 12/13/22 DECEASED  12-28-2022
Vasovagal event 5 minutes after administration.     Chart note: pt was siting in waiting room and states he started to feel like he was going to pass out, he  stood up to talk to receptionist at window and had vagal response and fell back against wall and slid to floor.   He was sitting up, diaphoretic but responsive when provider arrived to waiting room.   911 was called;  had him sit for a couple minutes then moved him to wheelchair and had him lay down on table with assistance, ice packs applied to neck and head and manual BP taken and was 96/54, pulse of 50, pulse ox 92% placed oxygen 4 L NC and pulse ox raised to 100%, pt felt better,  pulse still running 46-52 on pulse ox, EKG machine attached and pt repeat BP 102/62. ekg done and reviewed no acute cardiac concerns.Paramedics came and pt feeling better, they did orthostatic testing and pt BP was consistently over 106/60's, heart rate up to 68 they then walked pt and his wife outside to discuss transportation to ER for evaluation.   Patient refused transport to ED and opted to go home.
Covid 19-Pfizer Gray Top was diluted with 1.8ml of diluent in error. Patient received diluted dose
Pt's parent called hospital call center on 9/24/21. Pt's mother states pt got 2nd dose of Pfizer today around 4:30pm and pt started having rash all over the body. Advised pt's mother to take pt to the nearest ED immediately. Parent expressed understanding
shingles; Rash on right arm started to appear; Swollen lymph node above left collar bone/ swollen lymph nodes in right groin and right armpit; neuropathy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 18May2021 at 09:30 AM at age of 30-year-old as single dose for covid-19 immunisation. Medical history included anxiety and depression, Cephalosporins allergy. The patient previously received first dose of BNT162B2 (Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 27Apr2021 at 09:30 AM at age of 30-year-old as single dose for covid-19 immunisation. Concomitant medication included welbutrin 300mg long acting. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was diagnosed with neuropathy on 19May2021 at 7:00 AM (1 day after the vaccine), swollen lymph node above left collar bone on 20May2021 (2 days after the vaccine), swollen lymph nodes in right groin and right armpit on 21May2021 (day 3 after the vaccine), rash on right arm started to appear on 22May2021 (4 days after the vaccine), shingles on 23May2021 (5 days after vaccine). The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Valacyclovir 1gm tabs twice daily (2x daily). The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Shot was administered 10/1/16. On 10/07 pt had stomach pain, runny nose; 10/08 pt had headache, dizziness and chills; 10/09 pt said body felt heavy and had slight body aches (no fever). On 10/8 took Echinacea tea and TYLENOL, felt a little better, prev. used charcoal tabs for stomach?
Chickenpox, at least 200 spots, very itchy, lasted 6 days until scabbed over; was still contagious; 2 siblings came down with chickenpox, 15 days later.
Itchy rash on lower legs developed 5 days post vaccination; then spread to arms.  Continues
This case was reported by a consumer via other manufacturer and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 2nd dose of SHINGRIX. On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm were unknown. It was unknown if the reporter considered the headache, feeling unwell, chills, fever, muscle pain, fatigue, stomach discomfort, decreased appetite and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th May 2018, in the morning,  the patient woke up feeling ill and experienced a bad headache, chills, slight fever (the patient's body temperature was recorded as 100.4 degree F), muscle aches, and was extremely fatigued. The patient's stomach was somewhat unsettled and she did not have much of an appetite and had soreness in arm that she had expected. The patient had been taking Advil, on the day of reporting, to keep these symptoms at bay, which had been helpful, although she was still feeling washed out and tired. The patient searched SHINGRIX side effects and noted that others had experienced similar side effects based on information on the SHINGRIX website. The patient wanted to officially report these events as part of her Pfizer obligation to do so, but also to help get the word out to help the research continue with this important vaccine relative to the population that experiences these adverse events. The patient was not sure if there was any other information she could provide that might be of additional use. However, the patient agreed to be contacted for any need of additional information.
This spontaneous report was received from a certified medical assistant concerning a 69 year old female patient with no pertinent medical history or drug reactions/allergies who on 17-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). Concomitant medications included amlodipine besylate, CADUET, LANOXIN, aspirin, omega-3 marine triglycerides, metoprolol, TRICOR, magnesium (unspecified) + (glucosamine), ACTONEL, vitamin B (unspecified), ascorbic acid and multivitamin. On 17-APR-2012, the patient developed itchy red bumps scattered all over her body, after receiving a dose of ZOSTAVAX. No treatment was given for the events. The patient sought medical attention, went to the office. No laboratory tests were performed. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.