chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed with severe heart problems; Initial information receiveds on 27-Jan-2022 regarding an unsolicited valid serious social media case received from a consumer/non-healthcare Professional (hcp).  This case involves a 26-year-old patient (gender: unknown) who was collapsed with severe heart problems while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, collapsed with severe heart problems (cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as life-threatening.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 26 years old collapsed with severe heart problems. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (life-threatening) collapsed with severe heart problems.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapsed with severe heart problems).  At time of reporting, the outcome was Unknown for the event collapsed with severe heart problems.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 26-year-old adult patient who was collapsed with severe heart problems, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Pt. rec'd 2 flu vaccines - pt did not recall receiving 1st vaccine 9-21-12, so she requested another vaccine 10-26-12 & received that one as well. Pt. denies any adverse effects no known injury.
UPPER ARMS HURT A LOT, MASSIVE HEADACHES, CHILLS. I WAS REALLY TIRED AND SICK AND IT WENT ON FOR ABOUT 14 HOURS. FOR MY THIRD BOOSTER SHOT MY JOINTS WERE HURTING A LOT. MY ELBOW SHOULDER AND THE WHOLE BODY ACHED.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
PATIENT STATES SHE EXPERIENCED TINGLING OF TONGUE AND A METALLIC TASTE IMMEDIATELY FOLLOWING VACCINATION. PATIENT NOTIFIED PHARMACY ABOUT 1-1.5 HOURS AFTER RECEIVING SHOT. PATIENT WAS INSTRUCTED TO MONITOR SELF AND TAKE BENADRYL IF FEELING TONGUE SWELLING. ALSO INSTRUCTED TO CALL MD/GO TO URGENT CARE IF SYMPTOMS GOT WORSE.
The next morning I was unable to move left arm very much do to stiffness and pain. Shot area swelled up in an approximate 5 inch diameter, was bright red and very hot to the touch. Iced the area for 4 days before symptoms subsided and was able to use arm again. Then in 3 days all the symptoms returned again and lasted for about 5 days. Still a month later I have a small lump on the injection sight.
Information has been received from a 61 year old female with an allergy to penicillin and no pertinent medical history who on 19-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (dose, route not reported) in the arm. Concomitant therapy included LIPITOR. On 19-DEC-2008 the patient developed an itchy rash all over her body shortly after vaccination. The patient was not hospitalized. As of 23-DEC-2008 the patient's itchy rash persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 61 year old female with an allergy to penicillin and no pertinent medical history who on 19-DEC-2008 was vaccinated with ZOSTAVAX (Merck) (dose, route not reported) in the arm.  Concomitant therapy included LIPITOR.  On 19-DEC-2008 the patient developed an itchy rash all over her body shortly after vaccination.  The patient was not hospitalized.  As of 23-DEC-2008 the patient's itchy rash persisted.  Follow-up information was received from a physician who indicated that on 19-DEC-2008 the patient with hyperlipidaemia was vaccinated with her first dose of ZOSTAVAX (Merck) (lot number 662860/1617X) IM.  On 22-DEC-2008 3 days post vaccination the patient developed a purpuric "bury" rash on neck.  Concomitant therapy included LIPITOR 20mg and aspirin 81mg.  The rash was a bilateral dermatitic, nonvessicular errythematic on neck approximately 4X4 cm each.  Additional information has been requested.
bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consumer. An 18-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735, expiration date: unknown), via an unspecified route of administration administrated on left arm on 05Apr2021 at 16:00 at the age of 18-year-old at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other medications in two weeks. The patient did not have any known allergies. She received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, administrated on left arm on 14Mar2021 at 15:00 (03:00 PM) at the age of 18-year-old at a single dose for COVID-19 immunization. On 05Apr2021 04:00 PM, reported that the 2nd dose of vaccine caused unusual amount of bleeding after needle was removed. The patient had to clean excess blood after the shot. The band aid was soaked with blood. The patient experienced less soreness at the injection site compared to the first vaccine shot. The concern is whether the vaccine was bled out due improper injection. She did not have any other vaccine in four weeks before the covid-19 vaccine dose. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.
flu; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an a patient of unknown demographics who got the flu (influenza), after being vaccinated with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  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 at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) reporter stated to suffer from the flu (influenza) every year when the patient was obligated to receive INFLUENZA VACCINE during the military days. In addition, the patient also reported that post retirement in 2001 the patient had received INFLUENZA VACCINE at the most 3 times. It was not reported if the patient had any reaction out of the INFLEUNZA VACCINE received post retirement.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
I had been visiting my niece and nephew and they had been having some sinus issues. About 24 hours after getting home, I noticed some congestion and drainage. There was so much drainage my throat was getting sore. I went to the doctor, and they ran some tested that came back negative. They prescribed Amoxicillin for 10 days and I am almost done taking it now. I am feeling better now.
NSTEMI monitored and improved on his own; no surgical intervention needed started on imdur and losartan and discharged home
Starting the next day after the vaccine, I felt achy, tired, soreness in arm and felt a little under the weather. The follow day (day3), I was having shortness of breath and it took a lot of effort to walk and talk and I was extremely fatigue, no appetite and no energy. I went to the doctor and was put on albuterol inhaler, steroids (medrol dose pack). I took the medications and did not feel better. By Thursday (day 4), I could not get out of bed and slept for 20 hours. No appetite, I felt so weak, had a bad headache and difficulty breathing, could not get a full breath. I had no energy to do anything. I went  to the doctor (cardiologist) on Friday and got an EKG done (normal) and the doctor sent me to the ER. The ER ran a lot of tests and they came back normal except inflammatory was high and I was dehydrated. I was admitted to the hospital for 2 days and they ran a lot of test. I was not diagnosed with anything except vaccine related. I was discharged to go home and rest. It took a 2-3 weeks for me to feel back to normal.
Severe chills starting at bedtime;  no amount of layers could fix.  Felt like I was in the arctic without any protection.  Shivering was like I was having a seizure for about 3 hours.  Severe nausea to the point where I can hardly eat.  I'm down almost 5 pounds since Wed morning.  Severe headache since Wed night that feels like I have an ice pick in my forehead.  Excessive fatigue, sleeping about 16 hours Thur and today (Friday).  Severe dizziness when standing from a chair or bed; need to brace on wall for about five minutes before episode passes.  Loss of taste and smell.  Severe neck pain.  Photo sensitivity.  Runny nose and sever sinus pressure.  Maintaining a temperature of about 100 and 101.  Had to take off work Thur and half day off today, teleworking the other half.
This spontaneous report was received from a pharmacy personnel (administrator) referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (concentration, dose, lot number and expiration date was not reported) for prevention of shingles and subsequently developed shingles, no further description of symptoms was provided. The outcome of shingles was unknown. The causal relationship between shingles and ZOSTAVAX was not provided. Additional information has been requested.
Information has been received from a pharmacist concerning a 60 year old male with a history of rash caused by penicillin who on 03-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot no. 669533/1383Z, exp. 19-JAN-2012). On approximately 10-DEC-2010, reported as "a week later", the patient experienced "red dot rash without blisters" on the back of his arms and on his back, and "in prick pain" when lying in bed and while putting on a shirt. The patient sought medical attention via saw pharmacist. At the time of report, symptoms were persisted, patient did not recover. Additional information has been requested.
I had mild body aches over the weekend.  Then  I developed hives on Monday morning 11/29/21.  The hives were on my posterior neck, upper chest, thighs, underwear and bra line, both feet and left hand/ wrist.  I had mild swelling over my upper eyes and my lower lip was puffy/ full. The hives cleared up Tuesday.
Patient presented to the ED and was subsequently hospitalized for 12 days on 1/20/22 for COPD exacerbation. Patient presented to the ED and was subsequently hospitalized for 2 days on 2/26/22 for NSTEMI. These visits are within 6 weeks of receiving covid vaccination.
Received IM injection 10/28/15, then 11/18/15 pt informed pharmacist still had arm pain/weakness. Still sore but no nerve/joint pain. Said a little better - but feels her arm is weaker and generally hurts when moved/muscle pain. Pt still same Jan/Feb 2016. Will see diff MD.
After administering vaccine, a band aid was placed on the site. Child began to itch after band-aid applied. Redness at site began to spread to shoulder, neck and lower jaw on side of injection (left side).  Patient at no time expressed any distress with regard to breathing, sore throat, difficulty swallowing, eyes swelling, etc. Patient did itch at administration site. With parental  permission , patient was given 7.5mls of generic Benadryl. Within approximately 15 minutes, areas of redness were resolving.  Mother was instructed to administer a second dose of Benadryl after 4 to 6 hours if itching/redness continued. Mother was advised to seek immediate medical attention if symptoms progressed.
This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients received improperly stored vaccinated with VARIVAX lot # M041080 expired on 06-OCT-2018 for prophylaxis (strength, dose and route of administration were not reported). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effect was reported. The vaccines were stored at 6.3°F for 20 minutes. Previous temperature excursions reported were: 5.4°F for 10 minutes, 5.4°F for 10 minutes, 5.7°F for 10 minutes, 5.4°F for 20 minutes, 5.5°F for 20 minutes, 5.4°F for 10 minutes, 5.5°F for 10 minutes, 5.4°F for 20 minutes, 6.4°F for 1 hour, 5.9°F for 40 minutes and 5.7°F for 10 minutes. It was reported that the call was because of a data logger. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1708USA010711.
Arrived to ED on 6/8 with stroke symptoms, aphasia, slurred speech, left hemiparesis. Had had a colonoscopy earlier in the day where anticaogulation was held. CTH/CTA revealed right MCA occulsion. Given tNK and taken for thrombectomy. No improvement post procedure. MRI and CT head showed large evolving infarct with developing cerebral edema. Hyperosmolar therapy inititiated.  Fever and hypoxia developed on 6/12. Patient's family COVID + and patient tested and + also.  Discussion with family members and desired to proceed with comfort care.
Narrative: Patient is a 90 yo male. Patient received his first dose of COVID19 (Moderna) vaccine this date at 0925. Per RN patient was well prior to vaccine an after. RN waited 15 mins after vaccine per protocol. No treatment was needed in the home as patient seemed to tolerate vaccine well. Patient was eating breakfast and BG prior to vaccine was 168. RN left patient's home and received a call from caregiver reporting patient has what looked like a seizure; "shaking, confusion, not talking, eyes rolled back." EMS was called at 0959 and patient was taken by ambulance to hospital for further evaluation. Symptoms: Seizures Treatment:
Positive for Covid-19; Positive for Covid-19; Borderline diabetic; CLL; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself:  An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive for covid-19, borderline diabetic, cll on an unspecified date. Caller stated that he has a caller on the line that reported that had a test for antibodies and it was ok. He does not remember when he had the first and second doses of his Covid-19 vaccine and tested positive with Covid-19, but does not know if it was after the 2 doses. He is 85 years old. Caller asked, Will he get antibodies with the vaccines he has taken. Caller said that when he had the blood test it showed that he had antibodies his doctor said that he had Covid and fought it off.  Caller asked does he get antibodies from the Pfizer Vaccines. He had no symptoms that showed he had Covid-19. Caller said that he believes that he had the antibody test after receiving the Covid-19 vaccines. He said that he has CLL and is compromised health wise, has a couple of other things going on, and is borderline diabetic. The patient underwent lab tests and procedures which included antibody test: it was ok on an unspecified date (Had Covid and fought it off), sars-cov-2 test: positive on an unspecified date. The outcome of event was Borderline diabetic and CLL was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
I have been experiencing some side effects, lightheadedness, and fainting. This occurs when I stand up from a seating or reclining position.
Received 2 doses of Pfizer vaccine in April and May Two weeks (around April 22) post 1st dose of vaccine pt started experiencing chest congestion and hacking cough, some wheezing but no SOB and mild body aches, HA and fatigue. Symptoms lasted for about 2 weeks. Did not get tested for COVID-19 during this time. Started feeling well after 16 days and went for second vaccine. Two weeks post second vaccine (around May 15) developed sore throat, HA's, body aches, low grade fever, chills and sweating, minor queasiness and one day of diarrhea Symptoms started last week Lasted until now (May 26),  patient reports she is finally starting to feel better. Feels about 90% better right now.
Patient received 2nd dose pediatric Moderna at our clinic without issue. On 08.29.22, we found out that our pediatric Moderna vaccine was past its beyond use date. It was taken out of the freezer on 6.30 or 7.1 which would mean this patient received an expired vaccination. Moderna was contacted & investigated this LOT number, expiration date, and its viability. We received that this dose was still viable and confirmed this with our physician. I contacted the family to inform them of the error, the results of the Moderna inquiry and what Dr. stated. The family was extremely understanding and does not want to repeat their second dose of pediatric Moderna.
Shingles 3 weeks after 1st shot; Flashes in her right eye; Tingling and numbness in her right thigh.Tingling and numbness in her right thigh.; Fever; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HERPES ZOSTER (Shingles 3 weeks after 1st shot), EYE DISORDER (Flashes in her right eye), PARAESTHESIA (Tingling and numbness in her right thigh.) and HYPOAESTHESIA (Tingling and numbness in her right thigh.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced HERPES ZOSTER (Shingles 3 weeks after 1st shot), EYE DISORDER (Flashes in her right eye), PARAESTHESIA (Tingling and numbness in her right thigh.) and HYPOAESTHESIA (Tingling and numbness in her right thigh.). At the time of the report, PAIN IN EXTREMITY (Arm soreness), HERPES ZOSTER (Shingles 3 weeks after 1st shot), EYE DISORDER (Flashes in her right eye), PARAESTHESIA (Tingling and numbness in her right thigh.), HYPOAESTHESIA (Tingling and numbness in her right thigh.), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient stated that other adverse events were Shingles 3 weeks after 1st shot,flashes in her right eye, Tingling and numbness in her right thigh.   This case was linked to MOD-2021-416085 (Patient Link).
[after second dose] pain in my arm at the injection site; felt really really, super sick; couldn't even walk from my room to the bathroom; almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever; Fifteen minutes after the second shot, the lump appeared even bigger; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger). On 04-Mar-2021, the patient experienced ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom) and PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever). On an unknown date, the patient experienced VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 104 (High) 104. On 05-Mar-2021, Body temperature: low (Low) low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.   This case was linked to MOD-2021-356190, MOD-2021-356658 (Patient Link).