chrisvoncsefalvay/vaers-outcomes huggingface dataset:
awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open; awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open; scarring; painful; warm to the touch; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 20Sep2021 as dose 2, single for COVID-19 immunization. Medical history included, autoimmune deficiency/tolerance and Covid from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 26Aug2021 as dose 1, single for COVID-19 immunisation and after the first dose she developed little tiny red bumps like little fire ant bites and they kind a went away. Within 2 days after the second dose on an unspecified date in Sep2021, she developed awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open. These had developed all over her face, neck, arms and chest and are causing scarring. They were very painful and warm to the touch. They did not look like a blister they look like big bumps. She had been using Neosporin and surgical soap on it, but nothing was "touching" it. She was very worried about it. She had an autoimmune deficiency/tolerance but did not had AIDS. She stated her immune system was not good. She had already had COVID-19 and it almost took her life from her. Her doctor urged her to get the vaccine so she would not get it again. She had been to her doctor and dermatologist, and they did not know anything. The pharmacist told her it was a rare side effect of the vaccine that it was destroying her immune system. Patient received Neosporin and surgical soap as treatment for events. The outcome of all events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Tinnitus-Medium, Additional Details: extreme light sensitivity, muscle soreness, "bones ache", loss of taste and smell, back pain
Nausea; Exhausted; Every bone in his body hurt, and it feels like he has he Flu; Every bone in his body hurt, and it feels like he has he Flu; Dizzy; Headache, a splitting headache; Body aches, every joint in his body hurt; Rash, red, looks like fungus, from wrist up the arm, spots of white in between; Rash, red, looks like fungus, from wrist up the arm, spots of white in between; This is a spontaneous report received from a contactable consumer or other non-health care professional via Pfizer sponsored program. A 71-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot number: Unknown) via an unspecified route of administration in arm left on 23Mar2021 (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. Patient's relevant medical history included ongoing allergy to sulfa and undiagnosed skin condition of the hand from an unknown date and unknown if ongoing. Patient's concomitant medications noted steroid for an undiagnosed skin condition of the hand. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 Weeks. No Family Medical History Relevant to AE. On 23Mar2021, patient experienced nausea; exhausted; every bone in his body hurt, and it feels like he has he flu; dizzy; headache, a splitting headache; and body aches, every joint in his body hurt. On an unspecified date in Mar2021, patient experienced rash, red, looks like fungus, from wrist up the arm, spots of white in between. at first it was a light colored rash and It was all red, and she and the Pharmacist thought it looked like fungus. It was not itchy, it was not sore, it was not one whole patch, and had white in between. Nausea started the night he had the vaccine, exhausted started in the evening of the vaccine, body aches, every joint in his body hurt, Dizzy, Headache, splitting headache at night and all of his symptoms continued. Patient symptoms have lasted for 14 days today. Adverse events did not require a visit to emergency room and no visit to physician's office. Outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected
Rare spotting in between periods; No period for 3+ months; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: Ew0187) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE; CETIRIZINE. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Rare spotting in between periods"; AMENORRHOEA (non-serious), outcome "unknown", described as "No period for 3+ months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that no other vaccine received in four weeks. The patient did not have covid prior vaccination. The patient had been on birth control for 15 years with very regular periods, rare spotting in between periods on continuous method after no period for 3+ months. She was bleeding 2 weeks after her last period. Still on birth control and always had been taken regularly with no problems in 15 years.  Follow-up attempts are completed. No further information is expected.
my symptoms of fatigue, brain fog, headache, congestion, and cough returned; my symptoms of fatigue, brain fog, headache, congestion, and cough returned; my symptoms of fatigue, brain fog, headache, congestion, and cough returned; my symptoms of fatigue, brain fog, headache, congestion, and cough returned; my symptoms of fatigue, brain fog, headache, congestion, and cough returned; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), FEELING ABNORMAL (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), HEADACHE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), NASAL CONGESTION (my symptoms of fatigue, brain fog, headache, congestion, and cough returned) and COUGH (my symptoms of fatigue, brain fog, headache, congestion, and cough returned) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included COVID-19 (when I first contracted Covid, I had a fever of 102 degrees F for one day before it subsided.). Concomitant products included LAMOTRIGINE and FLUOXETINE for an unknown indication.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), FEELING ABNORMAL (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), HEADACHE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), NASAL CONGESTION (my symptoms of fatigue, brain fog, headache, congestion, and cough returned) and COUGH (my symptoms of fatigue, brain fog, headache, congestion, and cough returned). At the time of the report, FATIGUE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), FEELING ABNORMAL (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), HEADACHE (my symptoms of fatigue, brain fog, headache, congestion, and cough returned), NASAL CONGESTION (my symptoms of fatigue, brain fog, headache, congestion, and cough returned) and COUGH (my symptoms of fatigue, brain fog, headache, congestion, and cough returned) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 when I first contracted Covid I had a fever of 102 degrees F for one day before it subsided. On an unknown date, SARS-CoV-2 test: positive (Positive) when I first contracted Covid and negative (Negative) testing negative after first round of Paxlovid.         The patient was taking some unknown medications/products within 2 weeks of starting COVID-19 treatment. The device date was reported as 24-May-2022.  No Treatment medication was reported.
Approx. 2.5 hours, post vax, pt started to throw up and then stopped breathing. He was transported to the ER and hospitalized for 2.5 days. Scheduled for allergy testing on 9/6/01 concerning vaccines.
Injection site pain, swelling- 4 hours, Headache, fast heartbeat, chills - 12 hours, Low grade fever  99.7 - 100.2- 15 hours, Nausea - 18 hours, Vomiting, 1 time - 21 hours No treatment All resolved by 24 hours
pt recv vax;had 2 episodes of staring&unresponsiveness lasting 30-45 sec;EEg was done and nl;
My father developed non-Hodgkin's lymphoma soon after the booster shot he received in October 2021. Up to that point he was mobile and pretty healthy for his age. As soon as he received the booster shot (third dose) he started having severe back pain and extreme sweats.
On the 23rd of January I got chills and sweats for about 4 days and felt odd.
Acute onset of ataxia. Staggering gait, walking into the furniture and wall, frequent falls. Required hospitalization.
so weak and slept so much; my whole arm ached; "COVID arm"; my feet even ache; headaches that were horrible; fatigue was wicked; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache) and HEADACHE (headaches that were horrible) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache), HEADACHE (headaches that were horrible) and FATIGUE (fatigue was wicked). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 tablets a day and IBUPROFEN at a dose of 2 ibuprofen at night. At the time of the report, ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache), HEADACHE (headaches that were horrible) and FATIGUE (fatigue was wicked) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-075858, US-MODERNATX, INC.-MOD-2021-075839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075839:Cross linked case US-MODERNATX, INC.-MOD-2021-075858:Cross linked case
06/24/2022 I had a sore throat and a runny nose. The next day, I had congestion and started coughing. I assumed it was a cold. On the third day I tested positive for COVID at an Urgent Care. The doctor advised me that I needed to stay away from people for five days or 10 days recommended by the CDC. The doctor listened to my lungs and said they were not that bad, so she did not think it was advisable to prescribe an antiviral. I lost 10 pounds because I was not very hungry. Other than that, it just seemed like a cold. I took over the counter medicine for cough and congestion and finally cleared up. I stayed away from people for 10 days after the onset of symptoms. I isolated from my wife.   I fully recovered and am back to normal.
Troponin on admission was found to be elevated at 4.07.  CRP was also elevated on admission at 4.06. Patient was admitted for telemetry monitoring and cardiac evaluation. The echocardiogram showed normal heart function and no pericardial effusion.  Given the clinical description of his chest pain, the likely diagnosis was myopericarditis. Patient was initially prescribed scheduled nonsteroidal anti-inflammatories but this was subsequently discontinued as patient was chest pain-free.  Patient was started on colchicine. Serial EKGs were obtained which showed subtle changes but no pathologic findings. A repeat echocardiogram prior to discharge showed was normal.
1st dose- 1/14/21 Moderna lot# 013L20A 2nd dose- 2/15/21 Moderna lot #016M20A  On 3/19/21 I began to feel sick (headache/body aches). I have experienced severe headaches, weakness, extreme fatigue, mild cough, mild loss of smell & taste, severe body aches, loss of appetite, GI upset & dysphoria. As of 3/30/21 I am still experiencing weakness, fatigue, and GI upset.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,; vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,; 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), on 11Mar2021 as dose 1, single (Lot number: EN6206), on 04Apr2021 as dose 2, single (Lot number: EW0151), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8835), in right arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2022 as dose 5 (booster), single (Lot number: 059F22A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codine intolerance, reaction(s): "Known allergies: Codine intolerance". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "vaccine brand other=Moderna, vaccine administration date=28Oct2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date=02Apr2022,"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
the first one I just had real bad arm pain; I could not lift my arm for about 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset Aug2021, outcome "recovered", described as "I could not lift my arm for about 3-4 days"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "the first one I just had real bad arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278689 Same product, patient, different event, different dose;
Initially had a "lump" to the LT upper arm area. Site became red, and warm, and itchy approximately five days post initial injection. Developed chills.  Treated for cellulitis with Keflex, and advised oral/topical antihistamine and supportive measures.
Shortly after the vaccine I had a rush feeling like someone pushed IV fluids in really fast causing me to get dizzy and nauseaed.  I went home and took benedryl and tylenol which I did until about Wed when I finally was able to get up and  got nausea meds.  By the Monday of the next week the dizziness and nausea returned.  I  visited my dr. on Tues who gave Zofran for the nausea and Meclozine for the dizzines and by Friday I felt a little better and was able to return to work.  I experienced the up and down feeling within my body for about 2 1/2 weeks before all symptoms finally resided.  My brain felt foggy thoughout the entire time as well
Pt c/o lightheadedness and remained seated for approximately 15 minutes. Pt then left without incident.
(L) lateral thigh with areas of erythema 16 x 15.5 cm. (+) warm (+) min induration (+) tender
He was admitted to Hospital unresponsive as Ventricular Fibrillation cardiac arrest. Found to be COVID-19 positive upon testing on 5/31/2021. No prior positive tests on record.
Tics & stutter, started 9/30/20. Fever of 100.8 on 10/5. Sent to ER & f/u w/neuro.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown gender. On an unknown date, unspecified number of patients were inadvertently vaccinated with Improperly stored LIQUID PEDVAXHIB. No adverse effect was reported. No product quality complaint (PQC) was reported for LIQUID PEDVAXHIB. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 26-OCT-2007, was vaccinated IM into the right deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 655500/1005F). Concomitant therapy included a dose of FLUVIRIN (Lot# 80062) given IM into the left deltoid. After receiving the vaccine, the patient experienced pain in her left upper arm. It was reported that her pain was 10 on a pain scale with 10 being the most pain and the least amount of pain. Unspecified medical attention was sought. On 01-NOV-2007, the patient recovered. It was also reported that the physician advised when the injection was given a nerve may have been damaged. No product quality complaint was involved. Additional information is not expected.
Pt vax w/ Engerix-B dev ache in lt knee, bilat hearing loss, blurred vision lt eye, eye muscle spasm, has not ruled out MS, jaw numbness, painful salivation. 06SEP90 TESTS FOR VISUAL & AUDITORY BRAIN STEM EVOKED POTENTIALS = NL; MRI-HEAD=NL
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Received vaccine 3/9/21. On 3/12/21, he woke up with dizziness and nausea.
pt recv vax & devel hives;MD states that pt has been treating pt w/antihistamines & now w/H2 blockers for approx 1mo & the hives will not resolve;
PATIENT CALLED SEVERAL DAYS AFTER FLU SHOT COMPLAINING THAT HER ARM WAS VERY SORE AND HAD TROUBLE LIFTING HER ARM - PHARMACIST ON DUTY ADVISED HER TO APPLY WARM COMPRESS AND TAKE OTC PAIN RELIEVER (IE IBUPROFEN). TO CALL US BACK IF STILL HAVING PROBLEMS. PATIENT CAME IN TO PHARMACY TODAY AND SAID HER ARM WAS VERY PAINFUL AND SHE STILL HAD TROUBLE LIFTING IT. SHE SAID SHE RECENTLY SAW HER DR AND HER DR SAID SHE COULD NOT RECOMMEND ANYTHING MORE THAN WHAT THE PHARMACIST ALREADY DID. I INFORMED HER I WOULD COMPLETE THIS VAERS AND ALSO MAKE A NOTE THAT SHE DOES NOT WANT THE HIGH DOSE IN THE FUTURE.
I started getting a hives/ rash 11 days after vaccine. Still suffering from itchy skin, hives, red blotches of flushed skin, histamines etc. went to my doctor and they couldn't figure it out. Went to an allergist and he suggest Allegra.
9/7/2022 Moderna monovalent given not bivalent. We advised patient in 2 months they can return for a bivalent shot. Patient tolerated well. No adverse reaction.
The evening of the third dose I began to have a headache and body aches. As the night progressed it got worse I felt like my joints were locking and I got very cold. I had loss of appetites, nausea, vomiting and diarrhea. I felt the same the next day and was unable to work. I called my doctor to see what I needed to do and she stated it would run its course. Saturday and Sunday it slowly got better. I remained home from work Monday but was able to return on Tuesday.
swollen glands started on 16APR99 evening; c/o having hard time swallowing;also constantly clearing throat;glands were swollen on both sides x6 days;rash looked like hives;small red pinpoint area over entire body;T102.2;face swollen;
Patient complained of red, itchy rash starting on 4/2/2022. Consulted with pharmacist over the weekend, who recommended oral Benadryl, oral Zyrtec and topical Benadryl. Patient called clinic on 4/4/2022 and reported rash. Patient advised to continue with recommended medications. If rash continued to worsen to seek medical attention. Informed patient that inadvertent administration of expired vaccine (expired 3/25/2022) occurred. Offered to redo vaccination with suggestion of switching to a different vaccine because of the possible correlation with the rash and Moderna vaccine. Patient declined offer.
Patient reported to ER and was told to have cellulitis on the arm that was given the shot.
Patient has redness and sweeling at injection site that caused her to seek care at her doctor's office. Doctor applied warm compresses, gave her oral benadryl and called to report incident to us for reporting a few days later.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The nurse reported that on an unknown date these unspecified patients received improperly stored (Oka/Merck) VARIVAX (captured in MARRS#1408USA008605) and measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), (Oka/Merck) PROQUAD lot # reported as K003821 with exp date of 14-SEP-2015 and lot # K004713 exp date 02-OCT-2015, dose strength, site of administration not reported, which were exposed to a maximum temperature of -9C on multiple occasions, for undetermined timeframe (also reported that both vaccines were exposed to only -8.9C for only 15 hours). No adverse effects were reported. No Product Quality Complaint (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.