chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age (age: 74; unit- unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID 19 after the first dose of the vaccine. Reporter wants to know if the patient can be treated with monoclonal antibodies after having received the vaccine. Reporter also wanted to know if the storage in the thermal shipper can be extended past the 30 days. Event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events drug ineffective and COVID-19 are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Patient stated he was lightheaded after vaccination.  Patient stated he was anxious prior to vaccine administration.  No anaphylactic reaction after administration of vaccine.  Patient recovered prior to leaving clinic.
This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date 2 to 3 years ago, the patient was vaccinated with ZOSTAVAX 19400PFU (Lot# and exp date not reported) 0.5 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The nurse reported that 10 days ago (31-MAR-2013) the patient developed herpes zoster. The patient sought medical attention at physician office. Unspecified treatment was given for the events. The outcome of 10 days ago developed herpes zoster was unknown. Additional information has been requested.
black and blue bruising about three inches below injection site. Arm is blotchy, red and feels warm
Caller took his temperature under his tongue and the reading was 99.5°F last night/his temperature is usually 98 or 97°F/ he maintains his temperature around 96 or 97; some injection site pain; some body pains/ a lot of body pain; he could not sleep much states it was intermittent/He woke up every hour; his vision is not really good; He was experiencing an uncomfortable feeling in his body; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EK5730, Expiration date: Mar2021, at single dose on 17Dec2020, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231, expiration date Apr2021, Intramuscular at single dose in left shoulder on 04Jan2021 for prevention of covid. Medical history included ongoing Diabetes which was controlled with medication, blood pressure abnormal, microalbumin level that was high in urine, TSH was low. Concomitant medications included metformin for two or three years for Diabetes, lisinopril for blood pressure and kidney albumin control (he was found to have a microalbumin level that was high in urine and it was prescribed by his doctor several months ago. It was a kidney albumin control), and ongoing levothyroxine since TSH was low (now his TSH was normal and he was taking it per his doctor). The patient received his second dose of Covid vaccine yesterday (04Jan2021). He took his temperature under his tongue and the reading was 99.5°F last night. His temperature was usually 98 or 97°F. He took two Tylenol tablets last night and he did not go to work today. He also had some injection site pain. He had some body pains. He did not have these side effects with the first dose and understood this vaccine was more than the flu vaccine but he was concerned with the side effects. He received the second dose yesterday at 9:30 am. He did not have any problems with the first dose, absolutely nothing. Since last night he could not sleep much states it was intermittent, a lot of body pain, his temperature under the tongue is 99.5 degrees F and most of the time he checks his temperature with a frontal scan and he maintains his temperature around 96 or 97. He was calling to ask if the vaccine can cause covid infection. He did not have any problems yesterday at all prior to the vaccine being administered. When querying outcome of his body pain he stated it was mild. He took 2 caplets of Tylenol yesterday in the middle of the evening. He woke up every hour. He was experiencing an uncomfortable feeling in his body. His temperature was taken about 5 or 10 minutes ago and was 99.3 (states there may be a difference between under the tongue and frontal scan reading). He had to get his temperature checked behind the ear at his workplace since he was coming in from the cold outside. His blood sugar this morning (05Jan2021) was 101. His vision was not really good. Sometimes with the flu vaccine he got the same effect he was getting now but he did not worry about it with the flu vaccine. He received the flu vaccine a long time ago. The outcome of all events was unknown.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration were not reported, lot # K003604, expiration date 20-MAR-2015). On 12-MAR-2016, the patient was vaccinated with a second dose of ZOSTAVAX (in the deltoid region of the left arm, dose and route of administration were not reported, lot #L035285, expiration date 12-FEB-2016). There was no adverse effect reported. Additional information has been requested.
first dose: was pooped; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sepsis" (unspecified if ongoing), notes: The caller had sepsis a couple of months ago. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "first dose: was pooped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a medical assistant via a field representative concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) was "drawn up into a plastic syringe, stored in the refrigerator for 4 hours and then administered to the patient" (wrong technique in product usage process). It was outside the recommendations per GARDASIL 9 prescribing information. No adverse effects were reported.
the administration of an extra dose of Fluarix QIV to a 16 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 19-OCT-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season. On 19-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: the administration of an extra dose of Fluarix QIV to a 16 year old patient). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter called to ask for safety information regarding the administration of an extra dose of Fluarix QIV to a patient, which led to extra dose administered. The reporter gave permission to follow up but she did not provide an email address.
Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient was waiting in the observation area and reported not feeling right about 5 minutes after administration. She described symptoms as "adrenaline rush, anxiety attack". Patient reported heart racing and shakiness. 911 was called to the site and monitored patient for about 40 minutes. No symptoms of allergic reaction was observed. Patient refused to go with the parmedics to the hospital. She reported still feeling a bit shaky, but decided to go home on her own.
08/2021 I started having fluid in my lungs. COVID-19 test was negative. They determined it was Strep. I took antibiotics and that did not work. I then was diagnosed with bronchitis. In 01/2022 I had fatigue, body aches and it felt like the flu and strep. I had fluid in lungs and fever. I was given antibiotics and prednisone. I have been on an inhaler ever since. I am in the 3rd rotation of prednisone, antibiotics and inhalers. I am about to have pulmonary function tests to check on my lungs. X-rays are showing fluid that was not there in November 2021.
Patient jerked out of the vaccination site while vaccine was being given. Scratch at vaccine site due to jerking motion, all vaccine was not administered (less than 1/4 dose made it inside the muscle). Patient was unwilling to continue with vaccination, consulted patients that patient was not fully vaccinated and would need another administration to be protected.
Pt recv vax on 10/23/98; on 10/24/98 pt exp pain & swelling of lymph nodes in left axilla & breast for several day; felt tired & weak.
Onset of symptoms approx. 9.5 hours after vaccine included muscle aches, fatigue, chills. Approx 24 hour after vaccine symptoms included muscle aches, joint pain, chills, headache, fatigue. Symptoms of muscle aches, chills, fatigue improved but day three. Symptoms of severe joint pain have continued and have not improved. Joint pain is severe and limits daily activities with severe pain in hips, back, knees with  standing and walking. Other joint pain in hands, arms, toes is moderate.
A report has been received from a health professional concerning a child male patient. Concomitant medications and medical history were not reported. During 2012 August or September the patient received nasal FLUMIST. It was reported that the patient experienced breakthrough infections of influenza and also tested positive for Flu B, on 20-Dec-2012. Action taken with FLUMIST was unknown. At the time of reporting the outcome of the event of breakthrough infections of influenza was unknown and the patient recovered from the event of influenza B on an unspecified date. The event of influenza B was considered to be non-serious by the reporter. The event of breakthrough infections of influenza has been identified by the company physician from the source documents and it was added as non-serious adverse event.
Shingles; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137830, US-MODERNATX, INC.-MOD-2021-137922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137830:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-137922:Same reporter, different patient
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On 16-JUL-2009 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a hospital. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On 22-APR-2016 the patient was treated by a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
PATIENT CALLED ME TODAY EXPRESSING CONCERN OVER SIDE EFFECTS THAT WERE STILL LINGERING.  SHE STATED SHE HAS BEEN EXTREMEMLY FATIGUED AND HER LEGS HAVE "FELT LIKE LEAD" SINCE A COUPLE OF DAYS POST VACCINATION.  SHE SAID HER "INFUSION" SHE GOT TUESDAY USUALLY HELPS, BUT IT HAD NOT.  I ASKED WHAT TYPE OF INFUSION?  SHE SAID THE ONE SHE TAKES FOR HER SJORGRENS DISEASE.  SHE HAD STATED SHE HAD NO IMMUNE PROBLEMS AND DID NOT TAKE ANY IMMUNOSUPPRESSIVE DRUGS OR THERAPIES WHEN SHE FILLED OUT HER PAPERWORK ON 5/4/21.   I SUGGESTED THAT SHE CALL HER PHYSICIAN AS THE CDC RECOMMENDS FOR SYMPTOMS PERSISTING LONGER THAN A FEW DAYS.  SHE STATED SHE WOULD WAIT A FEW DAYS AND SEE IF THEY GOT BETTER.
SEVERE ARM PAIN, FEVER, CHILLS, BODY ACHES, HEADACHES, NAUSEA.
Right axilla pain and swelling. Applied ice packs and took ibuprofen. Which I was taking for the body aches. The same evening I noticed a rash. Under my breasts, creases of bilateral neck, face (mouth, eyes, chin and forehead), down small of my back and ceases in my legs. It was raised and red becoming itchy. I took Benadryl without relief. The rash has subsided. The right axilla is very tender and swollen. I did not have these symptoms for dose 1.
- chest pain 15 minutes after 1st dose was administered  - worsening chest pain throughout the week - chest pain when taking a deep breath in - chest pain when leaning back, laying down, or any position that increased pressure in chest - shortness of breath, especially when laying down - chest pain was pretty constant for about 3-4 weeks, worsened at times, and felt better at other times  - abnormal heart rhythm: rapid fluttering, felt like a bird was beating its wings against my chest trying to get out ( this occurred about 2 weeks after 1st dose, and only lasted a day. I had three 10-20 second episodes of this heart rhythm)  - chest pain is mostly gone now. I still experience some pain here and there when I move a certain way and shortness of breath happens a few times a day -
local reaction on left arm, red, warm and 3" red circle, increased HR 100-110 BPM (my normal is about70)
Pt vaxed 19DEC91 w/DTP/OPV/MMR/HIB fever of 104.8 R; given Pediaprohen & fever remained for a day or 2; As of 23DEC91 fever still 100 R (4 days);
Information has been received from a licensed practical nurse concerning a 25 year old female with no medical history and no known drug allergies who on 03-Jan-2007 at 08:48 was vaccinated intramuscularly with a first 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot #654992/0984F).  Concomitant therapy included ethinyl estradiol/norgestimate (Orthotri-cyclen Lo).  The patient received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) in error and was intended to receive her first dose of HPV VLP vaccine (yeast) (MSD).  No laboratory diagnostic studies were performed.  No problems had been reported.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  It was reported that the patient was vaccinated with a first dose of HPV VLP vaccine (yeast) (MSD) (lot #655619/1427F) on 11-Jan-2007.  Additional information is not expected.
Aug 9 or 10 had 2 spots on abd by the 10th she had c-pox like area on head, arm, abd. No fever that mom is aware of-child did state on the 9th she did not feel good.
Sore arm (left); Retinal detachment  (right eye); Flu like symptoms; Loss of appetite; Weakness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DETACHMENT (Retinal detachment  (right eye)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea). On 10-Jul-2021, the patient experienced RETINAL DETACHMENT (Retinal detachment  (right eye)) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (left)). At the time of the report, RETINAL DETACHMENT (Retinal detachment  (right eye)) had not resolved, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea) had resolved and PAIN IN EXTREMITY (Sore arm (left)) outcome was unknown.            Patient underwent Retina repair on 11-Jul-2021 and was prescribed with eye drops.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-297474 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
fever; This is a spontaneous report from a contactable physician. A 27-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Patient Age at Time of Vaccination:27) as a second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received historical vaccine of first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot EK9237 expiry: 30Apr2021) via an unspecified route of administration on arm left on 29Dec2020 10:00 as a first dose for covid-19 immunisation.Time vaccination was given: 10:00 (24 hour clock). On an unspecified date the patient experienced fever. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Causal Relationship: there is a reasonable possibility that the event is related to suspect products. Events were reported as non- serious. The outcome for the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
typical vaccine reactions within 24 hours (low grade fever, achiness, cough) that evolved into shortness of breath and chest pain.  Seen in the ER 36 hours later and treated with ativan with some decrease in associated anxiety but persistent dyspnea and inability to exertion.  Seen again in my office 48 hours later with very limited air movement on exam with pain with inspiration.  Treated with albuterol with immediate relief and better air exchange.  Sent home with albuterol and monitoring
Fever, aches, pains, heavy sweats, dizziness, nausea, loss of appetite, hallucinations, redness and swelling at injection site.
Information has been received from a registered nurse concerning a female patient who on approximately 16-Nov-2006, "about two months ago," was vaccinated with a 0.5 ml dose of GARDASIL vaccine. On approximately 16-Nov-2006, the patient developed swelling of the arm (unspecified) after the injection and experienced pain "in her whole arm." The patient sought unspecified medical attention. The patient's arm pain persisted. although, the outcome of the patient's arm swelling was unknown. Additional information has been requested.  This is in follow-up to report (s) previously received on 2/14/2007. Additional information received from the registered nurse indicated that the patient was vaccinated at another physician's office and provided no additional information. No additional informatin is expected.
I had UTI and pain I had to get up and pee over and over again. I was going from chills to fevers and having hot sweats. I had spent the entire weekend like this. I wasn't getting any sleep and in pain. I had to wait until Monday for testing. I was given a urinalysis. Before the results got back, I had a script for the antibiotic. I am still taking the antibiotic and feeling. As of today, I am symptom free and almost back to normal.
Moderna COVID-19 Vaccine EUA. Round, pink spots on torso. Growing in size and number since first appearance about two weeks after shot. Start as small dot. Largest now several inches across (on back). Flat surface, no scaling, no iching, no pain. No treatment.
In the evening I got uncontrollable chills (they were so strong it hurt). A few hours later I got a fever of 100.2. The injection site was red, swollen and painful to the touch. By the evening the area affected with 1/3 of my upper arm. On day 3 I am left with a severe bruise. The fever and chills lasted about 18 hours.
Patient reports that within 10-15 min after leaving clinic he experienced some confusion and "chills". Symptoms became worse over next 2-3 hours and lasted for 48hrs. Patient reports feeling "extremely cold", anxious & confused. Patient states he was in bed for 2 days but did not seek medical treatment for symptoms.
Headache, NauseaVomiting,  Swelling, Tinnitis  Narrative:  Missed 3 days of work so far due to the headache, 1 of the days she said it was a migraine. Hasn't had migraines in over 15 years..Headaches continue at this time 1/11/2021
T 102 on yesterday+chills this morning with red (right and neck) and swelling
no wheel created on 1st attempt to administer vaccine. 2nd attempt was successful on right arm