chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FM7553), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
The patient presented to the pharmacy and requested a pfizer vaccine after already receiving both doses of Moderna in april. She gave a different date of birth, so the profile did not show her previous vaccines
This report has been received from a pharmacist via Pfizer (MCN 2015091157) and refers to a 70-year-old patient of unknown gender. The information on concurrent conditions and concomitant medication was not provided. On 08-MAR-2015, the patient was erroneously vaccinated with PNEUMOVAX 23 instead of PREVENAR 13 (dose, route of administration and lot # not reported). Additional information has been requested.
pt recv vax 13NOV96 & 16NOV96 exp pain in lt ear & head;pt devel fever & face became puffy;also exp painful, weak muscles, neck, shoulders, arms, legs & has double vision & balance problems, wt loss cont;lump in rt arm;
after I got my first shot, I noticed once in a while I couldn't taste anything; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunisation (because they want everybody to have the vaccine and age). The patient has no medical history and concomitant medications. After the patient got her first shot, she noticed once in a while that she couldn't taste anything but that wasn't all the time. The patient stated that they want everybody to have the vaccine and age. And they started with the older people which that is her, she was 83 so that's the reason she was getting it. It was not a prescription; in her town, they are giving them free. So, the patient did not have to have a prescription. They went by age. The outcome of the event was unknown.  Information about Lot/Batch has been requested.
Client verbalized that she develops Bell's Palsy after all vaccinations.  Her physician has placed her on steroids prior to receiving any vaccine due to this.  Patient received her 1st dose on 8/28 and had started steroids and benadryl onFriday, 8/27 in preparation to receiving her vaccine.  On September 3, upon coompleting the steroid dose, she developed Bell's Palsy and still has a droopy L eye as residual.
It started with swelling in the area of entry of the vaccine, which was hot to the touch. It was also red and hives began to develop. Red spots and infected-looking sores started to show up all over her body, including her private areas. She also has had a fever. I have pictures, excluding the private areas, that are available upon request. It looks like she has chicken pox, which she was supposed to be immunized against, but it seems it only gave her the virus. I have been giving her some over-the-counter children's generic allergy medicine, Tylenol, and been spraying the most painful areas with an aloe vera gel spray.
Patient received Pfizer Covid-19 vaccine while sitting down then transfered to another chair. Approximately 2 minutes after vaccination, the patient witnessed her sister being vaccinated and reported feeling light headed. She progressed to being faint while seated and pale, so rapid response was called. Patient was transfered to  to be monitored and discharged home. Patient was noted to have had prior similar events while having blood draws.
Extremities limp; Lethargic; This spontaneous safety report was received by the Regulatory Authority on 25-OCT-2021 and forwarded to Agency on 27-OCT-2021 from a nurse.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events lethargy and gait disturbance.  No further information is expected since the reporter denied consent to be contacted.
red patch below her deltoid; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red patch below her deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH MACULAR (red patch below her deltoid). At the time of the report, RASH MACULAR (red patch below her deltoid) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm little bit swollen, the arm that I got the shot on; My body feels like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm), on an unspecified date in Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I took the COVID vaccine yesterday and my arm has a little bit swollen, the arm that I got the shot on. And my body is just like you know when you are, it just feels like my body feels like tired. I was wondering can I take Tylenol or no? I just have one more question, do you think I should be going to work today?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Got a little throbbing under my arm where the lymph nodes were removed; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer. Concomitant products included TAMOXIFEN for Breast cancer. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed). The patient was treated with CISAPRIDE (MOBID) for Adverse event, at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed) outcome was unknown. Treatment details included heating pad for pain in ears and drinking a lot of liquids. This case was linked to MOD-2021-330647.
Initial report received from nurse on 13 Jan 2010: A child under the age of 4 received a 0.5 ml dose of FLUVIRIN on 13 Jan 2010. No adverse event was reported. Outcome was not reported.
Later that evening after the injection, I had a fever it was low grade. It was 101 to 108. I had foggy brain and lethargic, my right eye and lip started drooping like I had a stroke. I had blurry vision. I had chills bone pain and muscle ache. I could not get out of bed. I was very fatigued with severe weakness. A couple weeks later I was still weak and fatigue. It had never gone away. Within a month I went to urgent care fever and sore throat. It was the worst pain in my life. I was sent home with no antibiotics, no medicine. I made an appointment with another urgent care and I was swabbed and the determined I had strep throat. It was giving me high fever. Ever since I had been sick, the sore throat weakness and feeling tired lasted until June. I have not been able to work. Now it has gotten worse in October. I have blurry vision, and the left side of my face is drooping down and slurring my speech. I made an appointment on October 29th with my PCP, I was immediately diagnosed Mycenae Gravis. I had to see a specialist. I have been weak. I cannot lift my arms, talk chew, swallow, all my muscles were affected. I am now on medication. I am still slow and weak. I have to use a motorized scooter to go get groceries for my family. I couldn't drive for eight months due to the blurred and double vision. I think the shot triggered my Mycenae Gravis. It has ruined my life. All my immediate symptoms after the shot got worse. I had to see a neurologist. I am an ICU nurse, and I cannot work anymore. I have lost everything. I constantly am Ill. I walk now like a hundred-year-old woman. In April of 2021 that was the last time I have ever worked. I am now waiting on disability; I have found out with this has no cure. I am losing my home.
Head ache; colitis - bloody mucus discharge; cough with phlegm; loss of sense of smell & taste; loss of appetite.
blood in their urine; This spontaneous case was reported by an other and describes the occurrence of BLOOD URINE PRESENT (blood in their urine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (blood in their urine). At the time of the report, BLOOD URINE PRESENT (blood in their urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Around 12 hours after dose injection started to experience shaking; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methylphenidate hydrochloride (RITALIN) and bupropion (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. The patient previously received 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 29Mar2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021 at 21:00, around 12 hours after dose injection, the patient experienced shaking. The episode only lasted about 15-30 minutes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of shaking was recovered on 19Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Three days after receiving second dose of Moderna, I received my period even though it wasn?t due for another two weeks. It was very heavy and huge clots of blood. I had intense cramps and headaches. My period lasted 9 days and is normally only 4 days. After this period, I went through my normal 28 day cycle. But every period since the vaccine comes with daily migraines that don?t go away with medicine. I have several headaches 1-2 days before my period, every day of my period, and a day after or so. This has been like clockwork since the vaccine and was never an issue before.
Ask to stay in clinic 30 minutes due to previous allergies.  20 minutes into observation ( 11:45am) started complaining to lightheadedness, pale skin,  was taken to emergency area, to lie down. Immediately started complaining of tight throat, itching, called 911, and administered 25 mg of liquid  Benadryl ( children's) at 11:56 am.  At 11:57 am started complaining of mild shortness or breath, 911 arrived, took over care.  started 0z and assessment.
chest pains; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:45 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (lot number: EP7554) dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 at 02:30 PM (at the age of 36-year-old) for COVID-19 immunization. The patient medical history reported as none and had no known allergies. The patient had no other vaccine in four weeks. It was reported that patient took concomitant medications in two weeks. The patient's concomitant medications were not reported. The patient not had covid prior vaccination. Patient stated that, she started experienced chest pains 29 hours after injection. Chest pains have been sharp and intense pressure at times. They occur for approximately up to 30 seconds and subside. Intervals of time between have been sporadic and intensity varies. They were more painful in the afternoon but have subsided slightly in pain and duration as the day continues to go on. Her sister also received the shot at on the same day exactly one minute before her (patient's sister) and she was experienced the same pains. On 13Apr2021 at 13:45, the patient experienced chest pains. The patient tested covid post vaccination. The patient underwent lab tests and procedures which included Nasal swab: negative on 02Sep2020, Nasal swab: negative on 31Oct2020. The patient received unknown treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421040 same reporter/drug/AE, different patient
Severe pain, left side of my head, close to my temple.  In addition, I experienced extreme blurred vision.  I had been reading some information regarding psychotherapy at the time of the onset of my symptoms.  I looked down at the words and could not comprehend their meaning and struggled with heir pronunciation.  the episode was brief.  Later, I noticed when I looked in the mirror that the left side of my face was drooping slightly and I am still slightly swollen under my left eye and my left cheekbone.  I also continue to have a dull headache.
Arm swollen from injection site to elbow.  Red, hot, painful, at same time, itchy.  Tried benadryl 2 days after didn't help.  took3+ days until it resolved.  Didn't happen with any of the other injections, although I had some usual pain at injection site previously.  Ist booster sent me to bed with chills, fever and aching legs.  Gone by next day.  (probably should have reported that one!)
I had tiny pain at the injection right away and then about 2 hours later, I had considerable muscle pain in that right arm (I have pain in both but the right arm swelled more and turn red on the flu side of the arms) - all of my joints and most of my muscles - and even the bottoms of my feet hurt. Everything hurt. At night I couldn't sleep. My eyelids stuck together to my eyes - it might have set off my Shogrens. It was very severe pain in my body. The pressure against the bed was even painful. It was hard to find a comfortable spot. Today I still have muscle pain in both arms. It's minor now. That pain throughout my body stopped about noon the day after vaccines - it lessened by midday and now it still hurts in my arms and arm joints.  Mostly muscle pain. No treatment.
MMR shot was linked to Kawasakis and cause red rash similar to that of Measles. It was later discovered that it was indeed Kawasakis. Her eyes turned red and she had a red rash over her whole body and her liver functions have not been normal sense. They have been elevated consistantly and they sky rocket during sickness. This has been unexplanable by doctors as to why her body reacted this way to the shot. She also developed Chikenpox during asprin treatmens for Kawasaki and seemed to confirm the link between the two. She was put in the hospital for IVIG. and then was put on asprin treatments. She has as a consaquence been hospitalised several time for her liver functions and she can not recover or fight even a cold with out the fear of pneumonia.
This non-serious spontaneous case, initially received on 31-Aug-2018, from a pharmacist (reporting on himself), 44-year-old, adult male patient. On an unspecified date, the vaccine, FLUCELVAX QIVc underwent temperature excursion (50 F) for 6 hours. On 30-Aug-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252380, expiry date: 31-May-2019, frequency, route of administration and anatomical site: not reported), that underwent temperature excursion. The Seqirus confirmed that, the reported batch number (252380) was of FLUCELVAX QIV PFS NH 18-19. No adverse event was noted. Non-significant follow up received from the reporter on 18-Sep-2018: The reporter confirmed that, the patient was administered with the suspect vaccine on 30-Aug-2018.
CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported.  On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.
Headache, Myalgia, Arthralgia, NauseaVomiting, Received Vaccine 12/28/20 and developed symptoms that evening chills, subjective fever, arm soreness with increased warmth and nodule, and fatigue