chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) received via Pfizer . A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included pneumonia from 1995 and ongoing, in 1995 patient caught an unknown lung infection in the , it almost killed her. When brother found her, her lips were blue and he could not tell if she was breathing. She had cough up stuff ever since, every day. And a walk around the block would have her breathing really hard. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient reported that after her second covid shot all that changed, she still coughed up stuff in the morning, but it was less, white to clear not green and less of it, still very sticky. She could go for a walk with her husband then and not be winded, patient thanked. The clinical outcome for the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history who on 04-JUN-2007 received her first dose of Gardasil concomitantly with a dose of Menactra. After administration of the Gardasil on 04-JUN-2007, the patient fainted, was unconscious for 45-60 seconds and exhibited tonic-clonic seizure-like activity. There were no laboratory tests performed. She sought unspecified medical attention. No treatment was required. The patient left the office fully recovered. Upon internal review, tonic-clonic seizure-like activity was considered to be an other important medical event. Additional information has been requested.
About 12 hours after I received the shot when I was about to go to bed I started shivering severely, after about 10 minutes of constant shivering I got a fever that reached 101.9. The shivering continued for a total of 35-45 minutes than subsided to just the fever and a headache. My mother said I was talking out of my head and didn?t make any sense. But I finally fell asleep and here it is 4 days layers those symptoms are gone but I still feel malaise.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 21-Sep-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment medications were reported.
Extreme fatigue,  fever 100.2, hands & face very swollen, no appetite.
Within 5 minutes of ZOSTAVAX, pt became lightheaded and felt weak. BP remained normal, pt not diaphoretic. Fluids, food and 20 min of rest resolved symptoms.
received the first dose / 2 years before and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The health care professional did not knew the exact date of administration for the first dose.  The health care professional  had no information regarding the expiration or lot number either.  No further events was reported.  The reporter consented to follow up.
Extreme fatigue, brain fog, sinus congestion, headache, eye twitching, nauseau, sore throat
Patient was 11 years old and 8 months at the time of vaccine No side effects noted.
Discharged. Patient  is a 86 y.o. male presented to ER with generalized weakness, recent fall, sore throat, and cough. The patient states that about a week ago he started having a sore throat and cough. He also has felt worsening weakness and fatigue. He states that he has fallen more frequently over the past week. He has a walker at home but does not always use it. He hit his head last night when he fell and was unsure if he lost consciousness. The last two days his weakness and fatigue became worse so he came to the ER today and he was found to be positive for COVID. His appetite has been decreased and he states that he has not eaten for 2 days. He also has been nauseous for a week but denies any vomiting or diarrhea. He endorses bilateral lower abdominal pain, however he states that this is a chronic problem and it is not worse than normal. He denies shortness of breath, congestion, rhinorrhea, headache, dizziness, lightheadedness, chest pain, constipation, or diarrhea.    CT in ER noted:1. No CT evidence of an acute intracranial hemorrhage or acute calvarial fracture.  2. Intracranial volume loss with superimposed remote small vessel infarctions and probable chronic microvascular ischemic change.   Patient was admitted to the hospital and given antiemetics and fluids.  Patient was confused on admission, and continued to have intermittent confusion throughout his stay.  When I see him in his room, he is alert, oriented, and appropriate.  PT/OT has recommended 24 hour care and home therapy.  Patient will be discharged home, with family who will provide 24 hour care.  Patient did have a fall in the hospital, and will need assistance when getting up and ambulating in his apartment.
Hardness, swelling and redness in Rt arm. Started Saturday and worsening swell. Seen in ER Sun given Atox.
red, warm, hardness at site on 5/20/04 evening; swelling. Script given if becomes worse. Contact with CDC; stated no treatment. Mom notified.
Had to take a nap; Had a sore arm /sore arm was the same as the first two; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Had to take a nap), PAIN IN EXTREMITY (Had a sore arm /sore arm was the same as the first two) and FATIGUE (Tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20H and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SOMNOLENCE (Had to take a nap), PAIN IN EXTREMITY (Had a sore arm /sore arm was the same as the first two) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Had to take a nap), PAIN IN EXTREMITY (Had a sore arm /sore arm was the same as the first two) and FATIGUE (Tired) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-363645, MOD-2021-363646, MOD-2021-363657 (Patient Link).
allergy (hives); allergy (hives); breathing weird; palpitations; tachycardia to 130-140/Heart rate increased; chest got tight; This is a spontaneous report from a contactable consumer. A 74-year-old female patient reported that she received the first dose of BNT162b2 (COMIRNATY, Lot number unclearly reported as EP or EF and then 7533) via an unspecified route of administration in left arm on 02Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Relevant medical history included dizziness (for numbers of years), arrhythmia (using BiPAP), sleep apnea and general aches. Concomitant medications were not reported. The patient did not have any prior vaccination within 4 weeks. About 5-6 hours after receiving the vaccine her chest got tight, heart pounding out of chest, palpitations, heart beat elevated, tachycardia to 130-140 and she stayed that way for an about an hour before it got better. Also the next day the caller reported looking at her home security footage and noticed that she was breathing weird, although she did not feel this side effect the previous day as she was more concerned about her heart rate. The patient had also allergy (hives). The patient took metoprolol and Zyrtec. Tachycardia, chest got tight, heart rate increased and palpitations were resolving, while outcome of the other events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0142) intramuscularly at left arm on 11Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included herniated disk L5 S1. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C), vitamin b complex (VITAMIN B), cefixime (FLEXERIL), calcium, magnesium, curcuma longa (TURMERIC). The patient previously received first dose of bnt162b2 (lot number: ek5730) intramuscularly at left arm on 21Dec2020 15:45 at single dose for COVID-19 immunization. The patient experienced chills, severe all over body aches especially left arm, headache, sleeplessness, on 11Jan2021 23:30. No treatment received. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
rash onset 07/17/10, upper extremities, pruritic initially, improved in symptoms and appearance over next week  N/V/D onset 07/28/10; mild temperature of 100.1
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215 and expiration date 05-MAY-2017) (dose and route were not reported).  No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Patient initially had bruising and arm pain due to administration of the vaccination in her left deltoid on 03/06/2021 as she reports the pharmacist said he "hit a vein" during administration. She states that after 1 day her arm pain resolved but she still had the bruising. On 3/15/2021 patient woke up with swelling, warmth, and erythema distal to her original vaccination site. She denies any injury to this area. The erythematous patchy area distal to her bruising is nonpruritic and nontender to palpation. Patient denies other vaccine reaction symptoms such as headache, dizziness, runny nose, sore throat, cough, chest pain, shortness of breath, diarrhea, constipation. I recommended that patient use heat 10min three times daily for reduction in swelling and continue to monitor this site for any changes. If any changes occur patient needs to call the office; patient confirmed understanding. Also advised patient to call office if any new symptoms occur of vaccination reaction; she confirmed understanding.
Erythematous macular rash on trunk from neck to buttocks and pubis. Within 3 days, rash was coalescing and becoming pruritic.  10/01 saw MD who prescribed Prednisone 20mg x 5 days and Hydroxyzine HCL as needed.  Rash did spread groin and very tops of thighs and underarms and very tops of arms.  Became lighter with medication but still present as of 10/07/2013.
Arm pain following vaccination.  Was found deceased the following morning (less than 24 hours after the vaccine). Death was not attributed to the vaccination; cause of death was hypertensive and atherosclerotic heart disease.
Patient is 11 YO and received 0.3mcg./0.3ml dose of pfizer vaccine instead of 0.1mcg/0.2ml
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case was created for 21 patient of the 24 patients involved. Concomitant medication was not provided. An under dose bivalent vaccines was administered to the pediatric patients for either their 1st or 2nd dose. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial. The patients age was between 6 months to 5 years. Patient was contacted and revaccinated with correct dose. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Fever 102.7 and higher for 24 hours; extreme headache and body aches.
Localized reaction. Erythema initially 1 in diameter, indurated, sore arm. Worse 12/24. Induration/erythema up to 3 inch diameter. Soreness obviously worse. Took antihistamines, tylenol. Today induration down to 1 inch, bruised  not nearly as sore.
Pt reports numbness above lip to right eye. Pt states she had some anxiety about injection and potential side effects, and wasn't sure if it was due to that. She states it resolved and is feeling fine.
Neck stiffness, dizziness, head pain, dry cough and difficult breathing. VS BP 140/80 P 70 R 16. 0.3 epi, transferred to ED.
Information has been received from a physician concerning a 71 year old female who on 8/27/06 was vaccinated with a 0.65 ml dose of varicella zoster virus vaccine live. On 8/31/06 the pt experienced a shingles like rash on her mid torso. The physician treated her with the anti viral Famciclovir (Famvir). There was no product quality complaint involved. The physician considered the pts shingles like rash to be an other important medical event (OMIC). Additional information has been requested.
Patient was given 0.4ml of undiluted Pfizer vaccine. Patient contacted, denies any adverse or local effects, merely a sore arm for 1 1/2 days after receiving vaccine. No treatment needed.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be AT Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; TADALAFIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (2022) Negative, notes: I had previously tested "negative" upon completion of the Paxlovid 5-day course; (03Jun2022) Positive, notes: I also tested "positive" with an at-home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Treatment drug included Paxlovid from 25May2022 to 29May2022. Five days after completion of Paxlovid treatment, patient again experiencing sympoms (sniffles, chill, body aches, sneezing). He also tested "positive" with an at-home rapid test. He had previously tested "negative" upon completion of the Paxlovid 5-day course. Patient had no Known allergies.
87 yo female with history of Parkinson's disease, HFmrEF 45%, autoimmune hepatitis, anxiety/depression, TIA, and CAD who presented to Hospital on 10/6/2022 with a chief complaint of generalized weakness and fatigue. She was found to be COVID-19 positive and elevated BNP concerning for acute on chronic HF. Diuresed in the ED with 1 dose of lasix and her kidney function improved. She required oxygen supplementation initially and was started on steroids and Remdisnivir. Hypoxia and SOB resolved. She was deemed stable for transfer to PRIVATE with continued COVID isolation until 10/15, however, COVID PRIVATE was unable to take patient. Family initially accepted home with home care, then started the appeal process. After a few days
Received first dose of vaccine 30 hours after it was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured) 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.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-132146 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132146:Crosslink
Severe headache after vaccine administration one hour ago; This is a spontaneous report received from a contactable reporter(s) Nurse (Other HCP).  A patient in their 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache after vaccine administration one hour ago".  Additional information: No underlying conditions young adult 30s.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: 94yo male died on 9/19/2021 at hospital (community hospital) who had hx of cad, afib, hx of cva, htn, hld, bph, gerd, gout, chronic back/shoulder/knee pain. Pt had receive covid vaccines on 1/11/21 & 2/8/21. Likely pt's death not related to covid vaccines given pt's advanced age, comorbities & long timeframe between date of vaccines & date of death.
A report was received from a health care professional on 12/8/03 concerning five children of unspecified sex and aged between 8 months and 3 years of age who inadvertently received Fluvirin on 12/6/03. On 12/6/03, five children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Follow up information received from a health care professional indicated that a 3 year old male vaccinee inadvertently received Fluvirin on 12/6/03. No adverse reactions have been reported to date. No follow up pending. All information received.
Information has been received from a certified medical assistant concerning a 74 year old female with rheumatoid arthritis, coronary artery disease and osteoporosis and a history cancer who on 16-JUL-2007 was vaccinated IM into the left deltoid with a 0.5  ml dose of PNEUMOVAX 23 (Lot # 655592/1175F). Concomitant therapy included LIPITOR, alendronate sodium (MSD), methotrexate, folic acid, PLAQUENIL, MEDROL, aspirin and torsemide. On 17-JUL-2007, the patient experienced an injection site reaction. Symptoms were described as swelling of the left arm, "hard" and erythema which extended to the elbow. Also, the patient had difficulty in lifting the arm. Unspecified medical treatment was sought. The patient was ordered on ice and TYLENOL. At the time of the report, the patient had not recovered. The medical assistant is requesting a lot check. This is one of three reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Seen by facility on 9-6-11 for PE and vaccinations. We received an ER report from hospital today. Contact hospital for further information.
Received 4 shots on 9-16-09. Upon waking 9-18-09 Left arm very swollen/hard/red. Mom took to urgent care later (9-18-09) - prescribed 2 antibiotics and told to use cool cloth off and on. 9-21-09 - TC to mom - child doing just fine.
Patient has a swollen and bruised injection site. Site got the FLUZONE HD on 11-02-2015. Patient came with complaint on 11-5-2015.