chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.
Mom reports that child became nauseated and would not eat. Started throwing up that night and continued to the next day. Child complained of body aches and also ran a fever of 102. Went to doctor on 7/27/16 and was told that he probably got a virus and the immunizations weakened his immune system. Gave anti nausea meds.
3 separate excursions with the same vaccines, total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes which was caused by human error with no reported adverse event; vaccines were administred to patients post excursion with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 months old female patient who experienced 3 separate excursions with the same vaccine, total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes which was caused by human error and vaccine was administered post excursion with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the 3 separate excursions with the same vaccine IPV (VERO), total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes which was caused by human error with no reported adverse event (product storage error) (unknown latency).  On 15-May-2023, the patient received a dose of 0.5 ml (frequency: once) of suspect of standard strength IPV (VERO) suspension for injection (lot: V1A021M, Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization, administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
pt recvd vax;LT arm pain,local swelling x 7 days; starting w/in 12 hrs post inj;LT arm, hand numbness, weakness starting approx 2 wks post inj; dx LT brachial plexus neuropathy;
This spontaneous report as received from a pharmacist, as part of a marketing research program, refers to a 65 year old female patient. There was no concurrent condition and medical history of the patient. On an unknown date in August 2014 (also reported as "11-AUG-2015"), the patient was vaccinated with a dose of ZOSTAVAX (administration, lot number and expiration date were not provided). No concomitant therapies were reported. On an unspecified date in August 2015, the patient experienced herpes zoster (shingles), for which she was currently taking some unknown medications as treatment. There were no diagnostic laboratory tests performed. At the time of the report the outcome of herpes zoster was reported as recovering. The reporter did not provide a causality relationship assessment between the event and therapy with ZOSTAVAX. Additional information is not expected, since there was no consent to contact the physician to discuss further.
Sore arm of injection site arm for three days.  Feverish and achy and fairly persistent cough and had head congestion and a very, very sore throat. Not constricted breathing.  June 15th.  It lasted three days. Persistent until I took Erythromycin .
This spontaneous report as received from a female patient of unknown age, who referred to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-SEP-2017, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On 22-SEP-2017, the patient was feeling weak, had a headache and flu like symptoms. The patient sought medical attention by calling a doctor's office. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Soreness in tendon at shoulder and in the bicep, soreness on range of motion with the shoulder.  In addition, redness under the skin (not on the surface of the skin) on the underside of the arm going from wrist to back of the arm by the triceps.  There is no pain with the redness.  It is in the opposite arm that received the injection.
Patient inadvertently received a dose of GARDASIL 9 instead of a flu shot on 10/7/2019 and patient was approximately 24 weeks gestation at time of vaccination; Patient inadvertently received a dose of GARDASIL 9 instead of a flu shot on 10/7/2019; This spontaneous prospective pregnancy report was received from a physician concerning to a 21 year old female patient. Information concerning the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 07-OCT-2019, the patient was inadvertently  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (strength, dose, lot # and expiration date were not provided), instead of a flu shot (wrong product administered), and patient was approximately 24 weeks gestation at time of vaccination (exposure during pregnancy). The estimated last menstrual period (LMP) was 20-MAY-2019 and EDD of 24-FEB-2020. The pregnancy outcome was outcome pending.
ADACEL was given on 8/6/11. Patient called us on 8/23/11. Patient said her arm was sore for 3-4 days then was getting better but after awhile it started to get sore again to a point that she can't lift her arm over her head.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Lot number: EL9262), in right arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Negative; (22Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received antiviral Paxlovid from 13Jul2022 to 17Jul2022 for treatment of COVID-19. Rebound Covid - tested positive again on 22Jul2022 after testing negative on 21Jul2022. Symptoms do appear milder that first time around.
Swelling of the lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "Swelling of the lips".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Open heart surgery eight weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (Open heart surgery eight weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC OPERATION (Open heart surgery eight weeks ago). At the time of the report, CARDIAC OPERATION (Open heart surgery eight weeks ago) outcome was unknown.            wondering if the vaccination is still effective because it is now been seven months since the second shot. Concomitant medication use was unknown Treatment information was unknown
Bilateral Hands erythema c no - dry skin reappeared a week after covid 19
Itching started within a minute or two of injection and has continued. Without being disturbed, the injection site has become slightly swollen (like a hive) and red, about 1.5 inches diameter around injection site, and remains very itchy 18 hours later. Fingers on that arm have been twitching, at times very rapidly.
Pt. seen at ER 11/27/07 with lump to injection site (LT) arm, redness throughout body & c/o lower Rt. back pain with burning upon urination, temp 101-102, took Benadryl 50 mg at 5:30pm, area is red & inflamed.  Onset of reaction 11/27/07.  Bactrim DS 2 tab po BID.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: PGJ2524), in right arm and on 27Dec2022 at 15:00 as dose 6 (booster), single (Lot number: GJ3274) at the age of 67 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "menopause" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug included Paxlovid from 01Jan2023 to 06Jan2023
A Moderna vial that was punctured first on 8/26 at 10:10am was punctured between 24 and 29 hours later for the patients administration. The vial was kept in the refrigerator (never leaving temperature) and was drawn up for the patient on 8/27 between 10am and 100pm.
Patient received routine flu shot in our patient health room while escorted by her mother. I reviewed the VAR with the patient and addressed if she had ever had any issue with previous vaccination and she stated no reaction except typical burning/stinging with previous COVID vaccination. After Vaccination she and her mother were informed that we recommend staying in the pharmacy area for 15-20 minutes for monitoring. Around 1 minute after leaving room patients mother knocked and informed me patient was not feeling well. As I was walking towards a seated patient she proceeded to black out. I was able to catch patient before hitting the ground and checked vitals. Patient was breathing and hot to the touch.  I informed on duty pharmacy staff to call emergency services and grab emergency bag. Patient became alert and verbal around 30 seconds after initial blackout. Patient stated slowly feeling better and only complaint was "feeling hot" patient was monitored until paramedics arrived.  Paramedics checked vitals again and patient was about to leave with mother. I called to check up around an hour after event and patients mother stated she was resting but feeling fine.
After receiving my vaccine on March 14th, I started experiencing pressure in the left side of my head and severe headache.  As the days progressed, I was continuing to have severe headaches for the next couple of weeks.  I was taking exedrin Migrane medicine to try and calm it down.   When I would try an work out it was worse, it was like the pressure on the left side of my brain was expanding and it would be worse.  My legs and body did feel weak.  It has slowly gone down with less and less of these headaches over the last couple of weeks.  They were definitely different than what a normal migrane feels like and very specific type of feeling.  I don't know if I have had any clots or not, but I am currently trying to get into a neurologist to get looked at to make sure there is not something else going on.  I am going to try and contact Johnson and Johnson to see if they can help refer to a neurologist because I currently do not have health insurance.
Pt recvd Engerix B on 27Jan92 for prevention of hepatitis B infection. Pt devel extreme fatigue lasting 12-14 days. No tx was given and pt is currently improving.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 11/2/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a nurse concerning an 18 days old baby. Patient's mother was vaccinated on 05-MAY-2009 and on 10-JUL-2009 IM with a first and second dose of GARDASIL respectively (lot number of the first dose unspecified and lot number of the second dose: 661953/1130X). It was reported the patient received the third dose of GARDASIL on 04-NOV-2009. the Medical Assistant reported that the patient received her third dose of GARDASIL while she was pregnant (LMP: 01-OCT-2009 and EDD: 08-JUL-2010). The mother's patient reported that on 23-JUL-2010, the patient was seen at the E.R. for a possible choking episode or possible increased temperature; she was not quite sure which. The same day the patient had a follow-up visit at the pediatrician's office and the mom reported her that the patient was doing well. Follow-up information was received via telephone call from a nurse who indicated that 2 weeks post-partum, the patient was seen in the hospital for a "choking spell". The patient was being followed by a physician. The mother experience was captured on WAES 0912USA00016. Additional information has been requested.
Delay in  otherwise regular menstrual cycle. Breakthrough bleeding/unusual spotting in between periods
Tingling and weakness in right arm; Tingling and weakness in right arm; Extremely heavy period; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10May2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 14:00, the patient experienced tingling and weakness in right arm, headaches, extremely heavy period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On an unknown date in 2021, post vaccination, the patient underwent COVID- 19 test via nasal swab and the result was not reported. The clinical outcome of the events tingling and weakness in right arm, headaches, extremely heavy period was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got a white circle around the where the shot was given, and it was itchy. still have it today (5 days later)
After 12-14  minutes after vaccine was administered, patient felt that her throat was closing up and she was given an epi-pen and the medics transported her to local hospital.
Two days after receiving the 1st dose of the shot, I had a severe headache. My left side of my body was sore to the touch. I could not move my left arm and my left hand was numb for over 24hrs. My lower back near my left kidney was sore. These symptoms did not subside for over a week. I had to use a heating pad nightly and take advil just to get some sleep. The second dose was worst. My head was hurting for over a week straight. Advil did not help with the symptoms. I could not see in bright light due to being sensitive to the light from the headache. I told my doctor about the symptoms the first time around and did not contact her about the second dose effects.
Narrative:  74yo male patient with PMH: Hyperlipidemia (SCT 55822004) Migraine (SCT 37796009) Lymphedema (SCT 234097001) Cellulitis (SCT 128045006) Hip pain (SCT 49218002) Chronic obstructive lung disease (SCT 13645005) Tobacco Use Disorder (ICD-9-CM 305.1) Essential hypertension (SCT 59621000) Morbid Obesity (ICD-9-CN 278.01 Diabetes (ICD-9-CM 250.00) died at hospital on 11/16/2021. Pt had received covid vaccines at place unknown on 2/4/21 & 2/25/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Non-productive cough; sore throat; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (sore throat) and COUGH (Non-productive cough) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 (Tested positive for COVID-19) on 03-Jan-2021.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 03-Jan-2021, the patient experienced COUGH (Non-productive cough). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and OROPHARYNGEAL PAIN (sore throat) and COUGH (Non-productive cough) was resolving.        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 relevant concomitant medications were reported.  No treatment information was provided.