chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vesicular rash above the right ear to the top of the head/ shingles; another vesicular rash on the right upper eyelid; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 30-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a vesicular rash above the right ear to the top of the head and another vesicular rash on the right upper eyelid (ophthalmic herpes zoster). The patient was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles and ophthalmic herpes zoster to be disability.   Upon internal review, ophthalmic herpes zoster was determined to be medically significant.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA377A, expiry date 31st August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided were as follows: The health care professional reported that a female patient received an expired dose of Menveo and the dose expired on 31st August 2021 which led to expired vaccine used. Reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Reporter consent to follow up.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Saturday, within 6-8 hours started with fatigue.  Then later that evening chills, headache, fever, and aches.  During the first night my ear started kind of ringing and feeling in a funnel or clogged or something (different from anything experienced before).  Sunday, continued with fatigue, headache, fever, body aches, generally not feeling well, and ear continued to get worse with some hearing loss.  Now today (Monday) I can't hear as well in my left ear and it's a type of ringing and still feeling clogged or in tunnel or something like that.  Hard to describe... but I can't hear as well in that ear.
Patient developed rhinitis, nonproductive cough, and dyspnea on 4/16/21. This progressed and patient went on to lose taste and smell. Patient received positive Covid test on 4/19/21 and was admitted for worsening dyspnea. Patient was discharged on 4/21/21.
Diarrhea and rash (diagnosed as Gianotti Crosti on 4/19/16).
Vaccine was administered very high on left arm at top of shoulder. I had the typical pain at the vaccine site, but then my left arm became numb/tingly all the way down to left thumb and arm has a burning type pain. The numbness and tingling are worse when sitting at a computer, etc.
I had really severe abdominal pain. I went to ER because of those symptoms. I was treated there. They determined I had a small bowel obstruction. I was hospitalized for three days and eventually was released. Gave me a solution that cleared everything out - no surgery or anything. To be honest, I'm still kind of having the issue. I have changed my diet around and can't eat normal food. If I do, I get pain back. I can't eat a normal meal anymore - I am coping but haven't recovered.
Post vax, pt had an adverse reaction. Left arm was swollen 5cm X 5cm with a greenish color; fever of 103.9F X 4 days.
Information has been received from a physician, regarding his mother-in-law, an 82 year old female patient with no known allergies, who on 18-DEC-2007, at 1:00 pm, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (invalid lot #, provided to physician from another office). Following the vaccination, at 5 or 6 pm, his mother-in-law experienced a heavy feeling of her arm. By 8 or 9:00 pm, she had pain all over her arm, and by 10:00 pm, she had developed a fever of 101 F, with induration on the deltoid that felt hot and tender. At the time of this report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Injection site pain, low grade fever (100.4 at last check), headache, fatigue
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored doses of COMVAX (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Patient reported after she left pharmacy, her arm swelled and felt on fire. She contacted Dr. He prescribed Prednisone. She is fine now 5 days of Prednisone.
Severe chest pain along with dizziness/lightheadedness started 2 hours after vaccine. Sx persisted for several hours.
Parents states blue color not breathing with seizure per ER? Febrile seizure 0030 Tempt 102.1 Dx at ER pulse Ox in ER 99%
just mild muscle pain; injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient previously received clindamycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and experienced drug allergy to clindamycin and amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies to medications, food or other products. On 15Apr2021 at 19:00, the patient experienced just mild muscle pain and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event mild muscle pain and injection site pain was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Lesions on the torso X 1 week. Today had approximately 50 lesions on the body, some scabbed, some raw. No current vesicles.
dizzy; very exhausted; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced dizziness and exhaustion. On an unknown date, the outcome of the dizziness and exhaustion were unknown.   It was unknown if the reporter considered the dizziness and exhaustion to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient administered Shingrix last Wednesday from reporting time. The patient had one good day but since then, he/she was dizzy and very exhausted, even after a decent night of sleep. The patient wanted to know how long will the side effects last. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a 15 year old female patient. On 30-OCT-2009, the patient was vaccinated with first dose of GARDASIL (dose, route of administration and Lot number not reported). On 07-SEP-2010 the patient was vaccinated with second dose of GARDASIL (dose, route of administration and Lot number not reported). On 02-NOV-2010, the patient was vaccinated with third dose of GARDASIL (dose, route of administration and Lot number not reported). No adverse effect was reported. Additional information has been requested.
After receiving the flu vaccine on 10/4/20 at 3PM, at 8PM that night for approximately 1 hr I had a rapid heart beat of approximately 110 beats per minute. My normal heartbeat is between 70-85.
pt recv vax; T 104; face swollen; apap given; T down; swelling gone down of face; lips still swollen & sore;
developed COVID symptoms 3 days after vaccine booster but it was not related to the vaccine; my husband developed COVID the day after my injection and I got COVID from him. All of my symptoms are related to COVID and not the vaccine. -significant flu-like aches all over, headache, chills, fever, cough, congestion...
.Headache left temple. Vision loss in right eye for approximately 10 minutes. Could see only whiteness.  During that time saw flashes of blue arrows flashing facing each other?s, also 2 imagines of black shapes like fish facing each other.  As vision returned sight was shaded and hazel.  Episode lasted for period about 25 minutes .
Significant pain 12 hours after vaccine given; inflammation, approximately 8 cm round and mild swelling at site.
shingles; ill-defined disorder; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 73-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and other zoster related injuries. The outcome of shingles and other zoster related injuries were not reported. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Approximately a month and a half later my husband and I came down with some type of virus. Our doctor has no idea what it was. None of the antibiotics given did anything and we were sick for 5 weeks. Now I am starting to feel sick again. The symptoms include fatigue, sinus pressure, sore throat, and coughing. I am also having trouble breathing and moving around. I still don't know what it is. My husband was tested for COVID-19, and it came back negative so I was never tested. I never had a fever either.
Information has been received from a health professional concerning a 21 year old male with developmental delay, sulfonamide allergy, and allergies to Tegretol, Dilantin, Rocephin, a history of spastic retro ganglion who on 04-SEP-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 623129/0550E) and a second dose of M-M-R II (lot #619236/006E). On 10 OCT-1997, the patient was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 622968/0686E) and a "Flu Vaccine" in the left arm, (Lot # 7t81898). Concomitant therapy included Singulair, Levoxyl, dietary supplement (unspecified), and unspecified anti-seizure medication. On 8 FEB 2007, a varicella titer was obtained. The results, show "antibody not detected. No adverse experience is related to this event. Medical attention was sought. The plan is to have the patient "return for a Varivax."
HALLUCINATIONS INVOLVING SEEING A DARK MAN-SHAPED FIGURE, WITHOUT ARMS OR LEGS, CRAWLING ACROSS THE CEILING AND ATTACKING AND CHEWING ON HER TWIN SISTER. TERRIFIED OF WHAT SHE WAS SEEING, CRYING.  LASTED APPROXIMATELY 45-60 MINUTES PER FATHER.
Fever 101-102. Chills (wearing winter coat and several winter blankets to get warm), headache, feeling of eyes popping out of head, muscle aches all over, and exhaustion. Feel like I have covid all over again.
DIZZINESS; MUSCLE WEAKNESS; HEADACHE; PAIN AT INJECTION SITE; MUSCLE ACHES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right deltoid. No concomitant medications were reported. On 18-MAR-2021, the subject experienced pain at injection site. On 18-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced muscle weakness. On 19-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aches, muscle weakness, dizziness, and pain at injection site. This report was non-serious.
The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking me up that first night with the pain. It felt like they were hot and aching, like they were working very hard, something I haven't experienced before. This was 5 days after my last period finished. I had spotting the next day, which I never have, and then my breasts became very sore, lumpy and tender for the next week or more - very concerning as I have had a fibroadenoma before. Symptoms were similar to being pregnant, but I have just started my next period, and did a pregnancy test which came back negative. I have also had ongoing light tinnitus, which started a few days after the vaccine. Again, I haven't had this  before, and it has been almost 3 weeks now and it is still at the same intensity. I am very worried about getting the second vaccine next week.
2 vial preparation was not mixed correctly. Only MenA (orange top) component vial was used and it was inadvertently mixed with 0.7 mL sterile diluent instead of vial of MenCWY component. It was administered into LD, pt tolerated well and did not experience any adverse reaction at this time. This is an ineffective vaccine though.
had the flu; Initial information was received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211021001175).  This case involves an adult patient with an unknown gender who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Definitely got my had the flu trust me please."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.
At 4 hours after vaccine placement, child started w/ severe headache and dizziness. Had x 1 short term blurry vision which cleared. Emesis x 1. Went to the ER and treated w/ antiemetic.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. On 29-DEC-2015 the patient inadvertently received a dose of RECOMBIVAX HB (lot reported as L030581 expiration date: 26-JUN-2017, dose was unknown) intramuscularly in the ventrogluteal site (drug administered at inappropriate site). No adverse effects were reported. Additional information has been requested.
Slight body aches started ~8 hours after injection, followed by chills, fatigue, and body aches at ~10 hours after injection. Took 2 Tylenol (500 mg each) at 12 hours after injection.  24 hours after injection, slight body aches and fatigue persisted. Took 2 Tylenol again at ~26 hours and at ~31 hours after injection to help relieve body aches. 48 hours after injection, no side effects were present.
Immediately after the injection child experienced a severe headache, pain at injection site, and some fatique. The severe headache has continued for 3 days.  Over the counter advil has not helped.  Headache is so severe that child is crying from pain.  Noises above a normal tone (including the sound of a piano playing) triggers the headache and worsens it.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's drug allergies and pertinent medical history were unspecified. On 14-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and route were unspecified). Concomitant mediations were unspecified. On an unknown date in October 2014, the patient developed rash on both her arms. It was unspecified if the patient sought medical attention and the treatment was also unspecified. The patient went to the pharmacy on 20-OCT-2014 and showed the reporting pharmacist the unspecified rash on both her arms, the patient stated that the rash was much better today than it was when she first developed it on an unspecified date in October 2014. The outcome of developed rash on both her arms was reported as recovering/resolving. The causality of rash on both her arms was not reported. No product complaint was reported for ZOSTAVAX. Additional information has been requested.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, GABAPENTIN, AMITRIPTYLINE, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved.            Treatment information was unknown.   This case was linked to MOD-2021-256793 (Patient Link).
Whole system went haywire; Abdominal pain; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Whole system went haywire), ABDOMINAL PAIN (Abdominal pain) and VACCINATION SITE PAIN (Pain at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.) Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (SLEEP TABS) and MEDROXYPROGESTERONE ACETATE (MENOPAUSE [MEDROXYPROGESTERONE ACETATE]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Whole system went haywire) and ABDOMINAL PAIN (Abdominal pain). At the time of the report, FEELING ABNORMAL (Whole system went haywire), ABDOMINAL PAIN (Abdominal pain) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15-Mar-2021, Patient had fitz maker test.  Treatment included none.
Vomiting for 24 hrs, 103 fever, stomach pain, pain throughout my body, headache not relived with Tylenol
Information has been received from a physician concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who on 30-JUL-2007 was vaccinated with GARDASIL (lot # 655849/0263U). There was no concomitant medication. The physician reported that the patient developed adverse reactions following vaccination with GARDASIL that started 2 to 3 weeks after the first vaccination. In August 2007, the patient developed body aches, general malaise, vomiting, weakness, bladder infection and arthralgias. The patient had no energy and was so weak that they could not get out of bed. The patient was examined at the clinic and unspecified tests were performed and the results were all negative. The symptoms persisted through the second dose of GARDASIL (lot# 657736/0389U) given on 27-SEP-2007. The patient was symptom free 4 weeks to 2 months prior to receiving the third dose of GARDASIL on 20-MAR-2008. The symptoms of malaise and weakness are returning after the third dose of GARDASIL. At the time of reporting the patient had not recovered from malaise and weakness. There was no other information to report. The reporter felt that the events were disabling. Additional information has been requested.
"Covid Arm" red, itchy, swollen, sore injection site. Appeared 8 days after 1st injection
High fever, chills, severe muscle and joint pain 10 hours after the administration of SHINGRIX 50 Mcg injection. Fever and lessened body aches continued for 24 hours.