chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In APRIL 2016, the patient was treated by a healthcare provider at a healthcare facility/clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Chills; Fever; Fatigue; Swollen tonsils; Achy body; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Sep2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Sep2021 at 00:00, the patient experienced chills, fever, fatigue, swollen tonsils and achy body. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event chills, fever, fatigue, swollen tonsils and achy body was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was injected with 1 syringe that was believed to be empty. This was recognized by patient and the shot administrator. Immediately after, decision was made to re-administer vaccine. A second injection was then performed, the second time with Moderna COVID vaccine 0.5 mL. Patient was counseled
Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given; Dose 2 given as 0.25; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported Moderna vaccine pulled from freezer on 16 DEC 2021. Beyond Use Date (BUD) Of 15 JAN 2022 printed in red and taped to the top of the boxes. On 26 JAN 2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point. Patient notified regarding error and that a repeat vaccine is not required and denied any adverse effects. Treatment medications were not reported.
with the first vaccine I had vaginal irritation; with the first vaccine I had vaginal irritation, redness; the skin started to peel; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Apr2021 12:15 (Lot number: ER8729) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; HYDROCHLOROTHIAZIDE; MELATONIN; TURMERIC [CURCUMA LONGA]. The following information was reported: VULVOVAGINAL DISCOMFORT (non-serious), outcome "recovering", described as "with the first vaccine I had vaginal irritation"; VULVOVAGINAL ERYTHEMA (non-serious), outcome "recovering", described as "with the first vaccine I had vaginal irritation, redness"; SKIN EXFOLIATION (non-serious), outcome "not recovered", described as "the skin started to peel". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulvovaginal discomfort, vulvovaginal erythema, skin exfoliation.  Additional information: patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 15:30 (Lot number: EW0182) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient informed that with the first vaccine she had vaginal irritation, redness, and the skin started to peel. She tried using vaginal suppositories but it did not work, she ended up using AZO for a few days and a natural gel which helped heal the area.  covid prior vaccination: yes, covid tested post vaccination: yes.  No follow-up attempts are possible. No further information is expected.
itches frequently; Not able to sleep; Shingles rash; Severe back pain; Shingles on her left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and BACK PAIN (Severe back pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles on her left side) and BACK PAIN (Severe back pain). On 01-Mar-2021, the patient experienced RASH (Shingles rash). On an unknown date, the patient experienced PRURITUS (itches frequently) and INSOMNIA (Not able to sleep). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Rash on face, at a dose of UNK dosage form; PREDNISONE at a dose of UNK dosage form and GABAPENTIN for Pain, at a dose of UNK dosage form. On 13-Mar-2021, BACK PAIN (Severe back pain) outcome was unknown. At the time of the report, HERPES ZOSTER (Shingles on her left side), PAIN IN EXTREMITY (sore arm), PRURITUS (itches frequently), INSOMNIA (Not able to sleep) and RASH (Shingles rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received .Patient's demographic details, Treatment product as Gabapentin, New event Severe back pain, Rash and Insomnia were added. Outcome of Shingles event added. Causality of Shingles event was added.
Received Engerix on 8/11/22.  On 8/12/22, began feeling fatigue.  on 8/13, began having generalized body aches, diarrhea, light-headed, feeling "hot", nauseated.  Felt "nodules" on face with pain to touch, and low back pain.  Later in the day, began having bottom lip swelling spreading slightly to top lip.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN, ATORVASTATIN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the event disappeared within 48 hours.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-027592 (Patient Link).
fever, severe h/a, muscles all over body is sore;stayed home from work 3 days;
He reports following his second dose of Anthrax vaccine (administered subcutaneously in December 2007) he developed limited local swelling after 1-2 days that resolved and then recurred as large local swelling (shoulder to elbow) one week later; he was treated with oral antibiotics with gradual improvement. He complained of headache and chills with this episodes but denies fever, myalgias, and arthralgias. In December 2008 he was evaluated by Allergy and it was recommended he receive his subsequent Anthrax doses via IM injection in conjunction with taking an oral antihistamine. He denies adverse reaction with this (his third) and subsequent doses in 2009 (fourth dose) and 2010 (he received two doses listed as fourth and fifth). In 2012 he received his next dose (seventh but listed as sixth) and reports he developed chills/rigors, myalgias, severe headache, and ringing in his ears the evening and following morning after receiving the vaccine. His symptoms lasted for the following 24 hours and then resolved. He denies rhino-conjunctival, cutaneous, laryngeal, pulmonary, and GI symptoms with this episode. He received Typhoid vaccine with his last Anthrax dose but has since received and tolerated Typhoid without adverse reaction. He denies adverse reactions to other vaccinations.
Information has been received from a nurse practitioner concerning a 20 year old female with an allergy to sulfonamides, who on 09-NOV-2006 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  On 08-FEB-2007 the patient was vaccinated with a second dose of Gardasil (Lot# 654885/1424F).  Subsequently, the patient developed an injection site reaction.  On 18-SEP-2007 the patient was vaccinated with a third dose of Gardasil.  On 18-SEP-2007 the nurse practitioner noted an 8mm reddish-brown mark with a central broken capillary at the injection site of the left upper arm, noted by the nurse practitioner to be "lower on the left upper arm, nearer the elbow" that had persisted since the second dose.  It was noted that the reaction was tender to touch.  The patient was examined in the office.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Mother states fine rash appeared yesterday on face, arms and legs.  Denies any on trunk, negative scratching. Temp increased to 101 last night. Monitor rash, give Tylenol and if rash worsens or no improvement, return to Health Dept or MD. Mother instructed. On 5/12/00, rash better and no fever. On 5/15/00, no rash or fever.
11/13/21 presents to local ED for "worsening dyspnea" "myalgias". PMHx of "HLD, GERD".
Itches; Hives and a red hive very hot to touch; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Tylenol.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever). At the time of the report, PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Complaints of polydipsia, polyuria, weight loss with polyphagia with onset during mid-late April 2009. When patient sought evaluation in May 2009, his BGs were elevated and he was admitted to Medical Center for 3 days with insulin initiation. He is currently taking LANTUS and ASPART to control his diabetes. He was medically discharged from the military.
Swelling at shot site, severe body aches and severe headache, red rings on right side of upper chest and beside shot site, chills (I felt as though I had a case of the flu--I couldn't get warm), shot site and right shoulder still quite sore almost 24 hours.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, expiry date 17-AUG-2018, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain on her arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 022C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for COVID-19.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (Pain on her arm). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of 1 dosage form. On 23-Apr-2021, MYALGIA (Pain on her arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Case number PHEH2014US003817, is an initial spontaneous report from a pharmacist received on 24 FEB 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A) intramuscularly on 23 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used an unapproved population".
Erythema, warmth and induration at site first noticed 24 hour after vaccine administration. Patient seen in clinic on 11/13/2020 and mother reported that the redness had improved
About 8 hours after receiving vaccine, patient we to ED with arm pain, redness, swelling and itching.  Was given Keflex 500mg QID X 10 days and instructed to take Benedryl OTC.
6:10 pm tired, sleepy, chills, trembling, teeth chattering, unable to talk normally. 09/04/22 arrived at ED 7:39 pm. Medication given in the ED. 11:48 pm Sodium Chloride 0.9 % IV solution, 1,000 mliv. 11:49 pm Acetaminophen. 9/5/20 1:45 am, discharged. 9/14/20, 2 pm f/u w/pcp.  Pt went to MC.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On multiple unspecified dates, the patients were vaccinated with recalled GARDASIL 9 lot # N029069 and expiration date 17-MAY-2020 for prophylaxis (dose, strength, frequency, and route of administration were unknown). It was reported that the patients did not experience any adverse effects.
Fever greater than 101.6 for 48 hours, muscle pain, bone pain, headache,  fatigue, chills, site redness, warmth and pain, skin painful to touch throughout body, loss of appetite
Hot flashes occured right after shot and was shaky (pt stated he has anxiety) hot flashes last about 5-10 sec and shakiness about 10 min. No treatment
Throat discomfort interfering with breathing, shortness of breath, tightness of chest.
Information has been received from a physician concerning a 13 month old white female with asthma, a history of sinusitis and no known drug allergies who on 21Sep04 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 648088/0100P). Concomitant vaccinations given on that same day included: the second dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 647099/1290N) given IM in the right thigh; the third dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (DTPA63902) given IM in the right thigh; the second dose of poliovirus vaccine inactivated (Ipol) (X1040) given IM in the right thigh; and the second dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) (A74398K) given IM in the right leg. At the time of vaccination the pt had a cough and diarrhea. The pt was exposed to child at daycare who had also received a dose of varicella virus vaccine live  and developed a rash (WAES0410USA04291). Subsequently, on 20Oct04, the 13 month old pt experienced vomiting, diarrhea, and a scattered papular urticarial rash following exposure. The pt was seen in the physician's office. The pt was noted to be fussy and without a fever. A rapid strep test was performed; the results were negative. It was reported that the pt recovered. Additional information is not expected.
Experienced panic attack, rapid heartbeat, trouble breathing and swallowing, burning sensation in my legs, itching in my legs and arm.  I was given  diphenhydramine 25 mg capsule and prednisone 20 mg tablet.
mild headache; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer(patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild headache. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache; the medicine size feels bigger and it swelled; Had a little bit of a lump where it was injected.; Is also losing her mind, cannot think straight anymore/Brain just not working; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 78-year-old female patient received the first dose of BNT162B2 on 02Mar2021 (lot number: EN6205) (at the age of 78-years-old) via unknown route of administration in arm at single dose; the second dose of BNT162B2 on 31Mar2021 (lot number: EP7534) via unknown route of administration in arm at single dose for COVID-19 immunisation. Medical history included: a little bit hard of hearing, which started before the COVID-19 Vaccine and concomitant medications were reported as standard vitamins. Patient previously took flu shot for little bit of a lump on unknown date. Headache began after the first dose COVID-19 Vaccine, 02Mar2021. Patient was also losing her mind, could not think straight anymore. Patient Had a little bit of a lump where it was injected. The medicine in her arm stayed quite a while like her husband's did. It was a lump. When she got the COVID-19 Vaccine, the medicine size felt bigger and it swelled. Felt a little tiny lump like the medicine was still there. The second shot was awful and did the same thing. She was stabbed in the arm for a while. It felt a little hard, did not know how many days later, but still had a lump. Now she did not have the lumps in her arm, but it stayed for quite a while. Weight was Around 100lbs, she did not change much. Her brain was just not working, it was terrible and she hated it. She could sit down and cry. About the Headache, there was not a time when it was better. Patient did not feel it when she slept. From the minute she opened her eyes, headache started, Stayed on, Constant pain. Probably had pain when she's sleeping, but did not feel it. About Brain just not working: patient did not know exactly when it started, did not know if it had to do with the COVID-19 Vaccine, the headache, or that she was an old lady. Right now, she was trying to get her brain to function. She was taking over the counter vitamins, Focus Factor. She would go through days that were worse than before. Told that when you got old, you lost some memories and so on. Patient was forgetting so many things now. Patient wanted to get quicker than other people, had a weak lung, heard coronavirus attacks the lungs first. In her age, she was healthy. When she had a headache, her doctor gave her a pill and she would take it. The outcome of the event headache was not recovered. The outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Second vaccine listed (left arm) was a flu shot but I have no information on the type or lot #. Severe HA; Severe Weakness-could not get up out of bed from 8pm Sat until 10am Monday. Very bad chest pain; extremely short of breath without moving; pain felt in bones in muscles, including cheek bones; severe numbness in face and bone cold in extremities with hyper chills. Wanted to call the rescue squad but was too weak to get help. Nausea, no vomiting, severe pain in kidneys.
First shot 3/8, second shot 4/5.  Around 4/27 I started to have minor, lower (mostly left) back pain.  It increased to severely painful at night and radiated down to my left knee.  The pain subsided after a couple hours after moving around and was either mild or non-existent until I laid down again.  On 5/4 I saw my primary care physician who prescribed muscle relaxant which, combined with ibuprofen did not address the pain.  Nighttime pain was resolved with oral steroids.