chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.
10:25 am vaccine administered,  patient observed to be sweaty, losing color in face and losing consciousness at 10:33 am.  Pharmacist held head until consciousness regained ( less than 5 seconds).  Patient was given water, a candy for possible low blood sugar,  911 was called and pulse,  blood pressure and blood glucose were checked.  Patient was transported to hospital for monitoring.
Approximately two weeks (14 days) after the patient received her flu shot she started experiencing rashes all over her body. She explained the rashes were bright red in appearance and itchy and at first sight resembled hives/shingles spots. The location of the bright red rashes were all over her left and right arm, her breast, chest, back, stomach, and pelvis. This was the second time after receiving a vaccine this had occurred and the patient used Hydrocortisone to stop the itching but did not make the hives go away. Spots she scratched left brown marks on her body.
Rash, fussy (mom has photos she can send). Rash appeared 7 days after vaccines; amox given. Rash now resolving.
2 LYMPH NODES APPEARED IN THE LEFT POSTERIOR TRIANGLE, MOBILE NOT TENDER, DISAPPEARED AFTER 2 DAYS, CBC 55% LYMPHOCYTES.CHEST X RAY NORMAL, CHILD LOOKS HEALTHY
Patient developed urticaria within 12 hours of the vaccine. Has subsequently developed chronic urticaria that has persisted through today's date. Urticaria is mild, easily treated with standard doses of antihistamines. No other systemic symptoms occurred.
Patient here for her 1st dose of Moderna Covid 19 vaccine.  Has a history of severe medication adverse reactions in the past and carries an Epi pen which she had with her.  Patient accompanied by her husband.  During her observation time, at 0735, patient complained about starting to have trouble swallowing which is similar to past reactions.  Nurse Stat called.  Epi pen administered at 0737.  ED here at 0738.  Decision made to take patient to the ED.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 19-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Previously administered products included BEXSERO (1st dose received on 18th September 2017). On 2nd August 2018, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient never received TRUMENBA. This is 1 of the 4 linked cases reported by the same reporter.
Pt. received PNEUMOVAX 23 approximately 3 pm and approximately 5 pm (2 hours later) his arm began hurting very bad. His pain was so that he could not touch the arm. Also had redness and puffiness.
The pt was given pertusis on 12/02/1999 and had his first seizure on 12/07/1999. He still has problems with seizures and he is now 2.5 years old.
Double vision from horizon down. Diag: vertical heterophoria. Cleared up in 6 weeks.
On 11/1 patient experienced redness, soreness and possible rash that extended down the arm. It lasted for a few days and it looks to be gone now. Patient reports slight redness now but feels fine.
Mother reports hypopigmentation to right upper arm in the shape of the bandaid applied to the vaccination site.
Patient called day of shot to report pain, swelling and redness on right arm that extends from shoulder to about 2 inches from elbow. "It's hard as a rock". No complaints of headache or fever but says feels kind of "fluish". Spoke to my supervisor who said suggest ice and ibuprofen. If no improvement or if swelling extends to fingers seek medical care
Within minutes after the vaccination I experienced a metallic taste in my mouth. I have continued to experience a metallic taste on and off for the past 4 days as well as today. Additionally, I had severe body aches, fatigue, and arm soreness and swelling, especially on day 2.
Narrative: Patient received his Moderna COVID #1 vaccine on 12/1/21 and on 12/3/21 he presented to an ER with c/o hallucinations, weakness, gait instability and lethargy. Work up in ER was unremarkable and it was not thought to be an ischemic stroke due to resolution of symptoms (unable to due MRI as Patient has a pacemaker). He was noted to be on apixaban, diagnosis unclear, and has had a CVA in the past. Also noted to active diagnosis of major depression and cognitive disorder. He was seen by neurology and plan is for outpatient follow up.
The day after vaccines, while swinging, the family noticed the patient had a fixed gaze and seemed to be not focusing on objects for more than 10 minutes. He has had none since.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received dose 2 on tuesday 1pm, after 12 hours the fever kicked in and lasted 24 hours through late wednesday night rendering me fairly useless. But that's not the event I'm reporting. On saturday, my period started, and it's literally the heaviest period that I've ever had in my life (and it's still going). I'm perimenopausal, and haven't had a period in 5 months, so at first I chalked it up to that, but the timing is suspicious so I asked around - there seems to be a lot of women who have been having off-schedule, very-heavy periods after their vaccinations. I'm a research scientist and I think this  is worth investigating to see if it's truly a vaccine effect and what the implications are, especially knowing that covid affects clotting. I've also submitted this info on pfizer's site.
Patient fainted after receiving vaccine. Was treated with 2L of oxygen, orange juice, and crackers.
Patient was instructed to wait in pharmacy for 20 minutes following administration.  Shortly after, he experience syncope while sitting.  He never completely lost conciousness, but was confused, sweating, and pale.  He said he felt dizzy.  EMS was called, and BP and pulse monitored until EMS arrived.  Pt became fully conscious a few minutes later.
ITCHING ON WRISTS, FOREARMS AND ANKLES; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 152 pounds, and height was 61 inches. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced itching on wrists, forearms and ankles. On 04-MAY-2021, the subject experienced rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over body, and itching on wrists, forearms and ankles. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Patient reported little rash, soreness on the right arm and back of arm and actual back on same; Patient reported little rash, soreness on the right arm and back of arm and actual back on same; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  little rash, soreness on the right arm and back of arm and actual back on same, feeling week and fatigue in the evening after receiving 2nd dose, patient started headache and severe joint pain(hips and back) ,patient got charlie horse on left calf, patient feels discomfort more on lower extremities as of now.  The patient's medical history was not provided. Concomitant medications reported were Metoprolol , Vitamin D, Vitamin B for drug use for unknown indication.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A)  in the left arm for prophylaxis of COVID-19 infection. On 1 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013A21A)  in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the event,patient reported little rash, soreness on the right arm and back of arm and actual back on same. On 1 Mar 2021, the patient experienced the event, patient started feeling week and fatigue in the evening after receiving 2nd dose. On 2 Mar 2021, the patient experienced the event,patient started headache and severe joint pain(hips and back) next day after receiving 2nd dose. On 4 Mar 2021, the patient experienced the event,patient got charlie horse on left calf. On 5 Mar 1903, the patient experienced the event,patient feels discomfort more on lower extremities as of now.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, patient reported little rash, soreness on the right arm and back of arm and actual back on same, patient started feeling week and fatigue in the evening after receiving 2nd dose, patient started headache and severe joint pain(hips and back) next day after receiving 2nd dose, patient got charlie horse on left calf, patient feels discomfort more on lower extremities as of now was unknown.
Broke out with blisters on left leg  and heal which scabbed and seeped. major area around blisters sorrounded by large rash.  Also broke out on leg and thigh on left and right leg.  On the first day of breakout my blood presure (taken at home) was 180/90. It in the 140's for the next three weeks. During third week of issue had a very hard time with emotions; anxiety, could cry at any time, thoughts of death, not suicide but what it was like to die.  Never in my 75 years of life have I experienced anything like this.  I am energetic and very positive.  Emotional issue lasted 1 week.  Entire reaction lasted 4 weeks.  I was seen by a walk in clinic and was diagnosed with poison ivy in the beginning. I sought a second opinion from my family physician who agreed.  I disagreed with both as I had not been any where near plant life.  I then saw my cardiologist who felt there was a possible reaction to a new BP med he had put me on a month before.  At this time I thought it might have been a reaction to the moderna 2nd shot, but did not pursue this until I recently have become aware of possible reactions with blisters and emotions.  I do have pictures of the reaction
Red swollen painful to (R) upper arm. Prescribed AB Tx as ER could not R/O cellulitis.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from pharmacist professional. This case involves patient (age and gender not reported) who was vaccinated with an expired dose of ADACEL (batch number, route and site of administration were not reported, Expiry date: 27-May-2018) on 04-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was not known whether patient had any adverse event. 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 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. List of documents held by sender: none.
No adverse effect reported; The female patient was administered a dose of expired PNEUMOVAX 23.; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 16-OCT-2019, the patient was vaccinated with her first dose of properly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot number N019348 with expiration date 08-FEB-2019 (expired product administered) (anatomical location, strength and dose were not reported) as age related vaccination (prophylaxis). No adverse effect was reported.   No product quality complaint was present.
Lots of red, itchy bumps, looked like bug bites on day one, more bruise like on day 2, quantity doubled between day 1 and day 2, ankles and hands swollen on day two, pt. indicated her ankles were painful to touch, further swelling in face on day three, more bumps on face. Visited Urgent Care, allergic reaction diagnosed as hives and started Benadryl on day three. PCP indicated the rash could be Erythema Multiforme.
I had my second vaccine on March 16, 2021 and three months later, on June 15, 2021, I developed tinnitus that continues to this day (9/26/2021).
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. No product quality complaint was involved. The vaccines were exposed to a temperature excursion of 51 Fahrenheit degrees for a time frame of 1.5 hours, identified because of a digital data logger. There was no previous temperature excursion. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008156: US-009507513-1709USA008154: US-009507513-1709USA008155:
Initial report was received from a healthcare professional on 04 October 2012. A male patient (age not reported) received an injection of FLUZONE HIGH-DOSE (lot number, route, site, and date of vaccination was unknown) and an unspecified amount of time later experienced elevated temperature, aches, and pains. Patient reported he was hospitalized for "reactions" from 01 October 2012 to 02 October 2012. Illness at time of vaccination was unknown. Pre-existing allergies and medical conditions were unknown. The patient's outcome was unknown. Documents held by sender: None.
Information was received on 14-JUN-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated  with a dose of ZOSTAVAX (lot and expiration not reported) vaccine on or about 13-FEB-2013 at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster and post herpetic neuralgia. On or about 12-AUG-2016,  the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as severe herpes zoster, or shingles. On or about 17-AUG-2016, the patient sought additional treatment from another physician for worsening symptoms, and the diagnosis of shingles was affirmed. On or about 09-SEP-2016, the patient sought care from a third physician, who affirmed the diagnosis of herpes zoster and began a regiment of gabapentin (manufacturer unknown) to curb her symptoms. On or about 21-MAR-2017, the patient was treated at a hospital for a new painful outbreak that onset on or about 02-JAN-2017 and had continued to cause severe residual pain. At this encounter, the patient was diagnosed with post herpetic neuralgia; a chronic condition of nerve pain and permanent residual damage secondary to shingles. The patient continues to be prescribed gabapentin (manufacturer unknown) at increased dosages, in attempts to manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report from a Medical Assistant reporting on behalf of a Health Care Professional  through Company Representative. A 17 year-old female patient received, on 11Aug2016, TRUMENBA (Lot. N16808, Expiration date: Jul2017) single dose, for immunization. Relevant medical history was unknown. Concomitant medications were none. On an unspecified date, the patient experienced neck stiffness, and neck pain at the left side where she got the injection. The patient's arm was swollen and red, and  hot at the injection site. Clinical outcome of the events was unknown at time of this report.
coughing; anxiety; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) or other non hcp reported. A male patient of an unspecified age (age: 63; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: was not reported) via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient experienced coughing, anxiety on unspecified date in Mar2021. Clinical course was reported as he (male age 63) received his first Pfizer covid shot today and when he got home, he learned his daughter tested positive for covid. If he was exposed, it. He took a test an hour ago but won't have the results until tomorrow. He has been coughing and taking Claritin. His daughter went out with a guy who had a running nose, and she has allergies too. He was not even tired. he ran 2 miles, and he has been exposed for over a week. The only thing he cough and anxiety. He'll just take his Zinc and Vitamin C. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on 18Mar2021 won't have the results until tomorrow. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of coughing, anxiety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extreme nausea (2 weeks after shot), headaches, loss of appetite, blurriness in left eye. Very tired.
Day 1  Wed a.m. vaccination Day2  Thurs - nausea/dry heaves briefly in morning around 10am Day 3  Fri - actual vomiting around 11am; son said feeling nauseated all morning up to that point Day 4  Sat - woke up with a stiff neck (back of neck) and low grade fever and chills with intermittent nausea - came and went similar to when had COVID last November but not as bad as the real thing but similar pattern Day 5  Sun - same as Saturday but sore neck went away Day 6  Mon - same up until around mid day; later that day had a headache -took Advil and cleared Day 7  Tues - woke up with a headache; took Advil and cleared Day 8  Wed - threw up again in the morning but thought that might not be related to COVID vaccine; in his mind, his symptoms related to the vaccine ended Monday early afternoon so 6 days including the day of the vaccine (no side effects on vaccine day - Wednesday), but really can't tell for sure one way or the other whether connected.  Question is whether he should get the second shot or not. Is 6 to potentially 8 days of side effects a concern? Also, parent has been curious as to whether son was a long hauler from covid for brain fog but son thinks it could be burnout from school. Strange that  had such a long lasting reaction compared to to others his gneral age, including those who had covid after he had it so longer ago.
This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 24-AUG-2105 at 08:49 AM, the patient was vaccinated with the second dose (reported as #1 elsewhere) of (Oka/Merck) VARIVAX injection, lot # L010145, subcutaneously in the right arm (dose and expiration date were not reported) that was improperly stored. The patient's concomitant vaccines given on the same date and time included HAVRIX (ped-adol, intramuscularly in the left arm) and poliovirus vaccine inactivated (unspecified) (manufacturer reported as Sanofi, 4 doses given elsewhere, intramuscularly in the left arm). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
FLUBLOK ADMINISTERED TO PATIENT UNDER AGE 18, NO KNOWN ADVERSE EVENT
EXTREME PAIN AND SORENESS IN HER ARM WHERE SHE GOT HER HIGH DOSE FLU SHOT.
Mother reports excessive fussiness for several nights and redness around injection site of right leg. Mother never called office with questions and infant was never seen in office for the issue.