chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Meningioma benign; Lyme disease; Itchy; Had no appetite; Had very red shoulders, chest and back; Sore muscles; This spontaneous report has been received from a 73 year old male patient concerning himself, via Pfizer. The patient's concurrent conditions included a penicillin allergy which he developed when he was a child (he was about 10 years old at that time) and he had not had any penicillin since. He had not ever had an anaphylactic response to anything. His medical history and concomitant therapies were not reported.  In October 2016 (also reported as about 5 years ago), on a Friday afternoon, and recommended at yearly check-up, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the left arm for prophylaxis (dose, route of administration, lot number and expiration date were not provided).   The patient stated that he had a pretty good response to the vaccine at the doctor's office, then that night he went out to dinner and had a few drinks at a wedding party. He stated that the next day, which was Saturday, he had sore muscles (myalgia), was itchy (pruritus), had no appetite, and had very red shoulders, chest and back (erythema); and he felt worse as the day went on. Moreover, He stated that he was at a wedding and did go to the wedding reception, but probably should not have with the way he was feeling. He also stated that he was recovering better by the next morning, so it only really lasted for about 1 day.   In approximately 2017 (reported as about 4 years ago), the patient experienced lyme disease, and eventually it went away.  On an unknown date, the patient experienced meningioma noncancerous (meningioma benign). In October 2019 (reported as 2 years ago), he had a brain surgery. For the meningioma noncancerous, the patient had magnetic resonance imaging (MRI) since then; the last one was in December 2020 and it was perfect.   The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, meningioma benign and lyme disease were determined to be medically significant.
Severe dermatitis. "Broke out with red bumps from shoulder to elbow. Had itching, swelling and burning at site of injection and from shoulder to elbow of left arm". MD gave him salve that helped reducee itching, swelling and burning.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-year-old female patient 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.    Concurrent medical conditions included Rheumatoid arthritis, GERD, Penicillin allergy and Sulfonamide allergy. Concomitant products included ABATACEPT (ORENCIA) from 10-May-2022 to an unknown date and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from 01-Oct-2021 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information provided  The patient had past drug reaction allergy. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously receives a COVID-19 Vaccine. Device date was reported as 23-May-2022. Reported Event: I finished the Paxlovid and felt better. Five days after finishing felt sick, low grade fever and cough. Five days later still feel about the same. Device Date : 23May2022  Company comment- This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced unexpected, non- serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient felt better after finishing her course of Paxlovid. However, five days after she felt sick, had low grade fever and cough with no relief. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced unexpected, non- serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient felt better after finishing her course of Paxlovid. However, five days after she felt sick, had low grade fever and cough with no relief. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Prior to having COVID-19 infection, I had three weeks of respiratory illness that lingered and became complicated with allergies. After three weeks of the respiratory illness, it moved to Bronchitis and Pneumonia. I was prescribed an antibiotic, erythromycin. At this time, I was testing negative for COVID-19. 2 days after taking the antibiotic, on 04/08/2023, I tested positive for COVID-19 with home test. I was prescribed PAXLOVID on 04/08/2023. I never really experienced any significant COVID-19 symptoms other than fatigue. Just the symptoms that I was already experiencing with the respiratory illness. After taking the PAXLOVID for 5 days I tested negative on 04/14/2023 and I was feeling pretty good. I have been healthy ever since.
Chills with chattering teeth.; Tightness in throat; difficulty breathing; lightheadedness; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that, a 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:00 (Batch/Lot Number: Ew0162) as dose 2, single (at age of 50-years old) for covid-19 immunization. The patient medical history included allergies to Histamines, FQ drugs, and cigarette smoke from an unknown date and unknown if ongoing. Concomitant medication included vitamin c (ASCORBIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 Solution for injection, via an unspecified route of administration, administered in Arm Left on 27Mar 2021 09:00 AM (Batch/Lot Number: En6207) as single dose (at age of 50-years old) for covid-19 immunization. There was no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced chills with chattering teeth, tightness in throat, difficulty breathing, lightheadedness on 18Apr2021. It was reported that, 15 hrs after injection, Chills with chattering teeth and Tightness in throat that would come and go. Lasted 4 hours. Some difficulty breathing (Took Benedryl) Some lightheadedness on 18Apr2021. The patient taken Benedryl for difficulty breathing and no treatment for other events. The outcome of the events was resolving at the time of reporting.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021343956 similar report from same reporter
achy joints/deep joint pain; achy joints/muscles; breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough).; Normal muscle fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 18:30 (Lot number: 32030BD) at the age of 35 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8780, Location of injection: Arm Right), administration date: 07Apr2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:30, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/deep joint pain"; MYALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/muscles"; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "recovering", described as "breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough)."; MUSCLE FATIGUE (non-serious) with onset 18Nov2021, outcome "recovering", described as "Normal muscle fatigue". Therapeutic measures were not taken as a result of immunisation, arthralgia, myalgia, dyspnoea, muscle fatigue.  Additional information: It was reported that beyond that 48 hour after the booster (3rd) shot, the patient continues to have achy joints, muscles plus some minor breathing issues. Normal muscle fatigue was normal with working out etc. However, the deep joint pain, difficulty breathing heavily during exercise (lungs don't feel like they expand or breath in enough). The patient reported that the events are nothing severe however it was persistent and not normal based on her body before the booster vaccine. No issues persisting after initial, or 2nd dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sunday morning, around 12:10am, I started getting chills/trembling/body shakes and my muscles all over my body ached. I was so miserable all morning I couldn't hardly sleep and later that morning, I could hardly stand for more than 5 minutes. That lasted all of Sunday and I maintained a mild headache. I drank a lot of water all day and ate very little.  I thought it would pass by the next morning. At 2:30am Monday morning a 2nd wave hit me, I had more trembling/ body shakes, this time it lasted for a little over an hour. I woke up again and again through the night and in the morning I had a terrible headache and nausea and vomited to the point of dry heaving. I slowly drank water with electrolytes.  At around 6pm Monday, I am finally starting feel normal again and made a meal of eggs and bacon with toast and felt fine afterward. I have had no other symptoms since that day.
Mother reports child "feeling bad" on 8/23/11. Child reports noting itchy red bumps on hands on legs at school on 8/24/11. Denies fever. Mother brought child into clinic. Multiple vesicular lesions noted on both arms and both legs. A few sparse red lesions noted on trunk. Mother was advised by RN to treat child with OTC Tylenol prn fever and OTC Benadryl or anti-itch cream prn itching. Mother was advised to keep child out of school until lesions have crusted over. Told to follow-up with PCP prn and if condition worsens.
severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath
swelling & pain at inject site x 5 days then had tingling at the arm & lower back. Now (6/24) has tingling on ribcage. Treatment - acyclovir, prednisone -> new RX *refill prescribed previously as preventative for HSV acyclovir was not new therapy Pt refilled old RX for HSV (previous diagnosis) MD called in prednisone as treatment 6/24/19
Immediately after administration, the site of injection developed a welt about 1/2 the size of a golf ball, a rash developed, and patient felt warm. 911 was called, EMT evaluated patient and deemed her to be well.
Information has been received from a newspaper article concerning an 18 year old female who in September 2007, was vaccinated with a first dose of Gardasil.  It was reported that shortly after the shot, the patient felt an overwhelming aching heat in her kneecaps and ankles.  After 24 hours, it spread to the majority of her bones.  Approximately one month after the shot, her body practically went through "withdrawals from missing the vaccinations".  The patient once again had aching bones and "this time cold sweats were involved."  The patient's eyesight had been more blurred since vaccination with HPV vaccine.  The patient developed her first varicose veins all over her thighs and ankles, and her bones hurt from even the softest pressure.  The outcome of the patient's experience was unknown.  Additional information is not expected.
COVID PFIZER-BIONTECH vaccine was administered to the left arm of the patient. Right after the shot was given, patient felt sick. He then made some shaking involuntary body movements then passed out right after. We called 911 for an ambulance. In the mean time, patient regained consciousness after a minute, felt dizzy, and threw up. His face was red and sweating. Paramedics arrived and checked his blood pressure and glucose. His blood pressure was abnormally low for the first 2 readings. We waited a couple of minutes to re-measure and it went back to normal. Paramedics. advised him that they transport him to the hospital to get further evaluated, he refused. Pt stated that he is scared of needles because of an incident that happened when he was given IV at the age of 12.
VOMITING (unsure if due to chronic condition though he hasn't vomited in at least 3 weeks) and 'TINGLY' LEGS- not quite pins and needles, no numbness, no pain, just aggravating tingling sensation
area knee to hip lt leg black & blue; states so swollen can't move leg well; 1/2 dollar area hard-red/warm began this PM; sl red bruised yest-100 not fussy;
Hospitalization for COVID19 7/24/21 and death 08/02/2021
This spontaneous report was received from a certified medical assistant concerning a 64 year old patient of unknown gender. On 25-OCT-2013, the patient was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
I began experiencing spontaneous hives 11 days after my booster. The hives first appeared as itchy welts on my back, butt, groin, and armpits.  They have since appeared all over my body as flat red lines. My skin also reacts more sensitively to scratches. The currently hives appear randomly and last about 20 - 30 minutes, with a hot, burning sensation. I have not had any prior allergic reactions similar to this and there has been no change in my diet, product use, or environment. I used Zyrtec 10mg/day for 2 days and then increased to 40mg/day for 5 days along with Prednisone 40mg/day. I am currently on 10mg/day of Zyrtec. The severity and frequency of urticaria has reduced but still occurs daily.  I did not have any adverse reactions to my first two Moderna COVID-19 vaccines.
Patient got a rash on extremities and whole body started 3 days after a vaccination and came back to pharmacy on 10/12/2021 to report it. Patient was advised to use OTC Zyertec 10mg and follow up with primaray care physician.
Apart from headaches and general nausea I began to shake uncontrollably around 5pm which lasted about 15 min. Then later in the evening it happened again but this time it was hard to breathe because everything in my body was so tight. This lasted until I got into the shower with the temperature set as hot as I could.
menstrual cycle has changed from 4-7 days to 2 weeks. I has consistently been every 2 weeks since the second dose of the vaccine was administered.
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
Patient developed a rash that involved the entire upper arm.  Rash expanded from elbow to top of arm.  Also developed a low grade fever of 101 degrees.  Patient reported not feeling very good.  Onset of event was approximately 24 hours after receiving the vaccine.  Patient was started on an antibiotic and a steroid taper 2 days after the vaccine.  The condition then resolved itself.
Discharge Provider: MD Primary Care Physician at Discharge: MD   Admission Date: 3/26/2023  PRESENTING PROBLEM: Septic shock (HCC) [A41.9, R65.21] Cellulitis [L03.90]    HOSPITAL COURSE:   Per ICU Course: " Patient is a 63 y.o. male with a past medical history of HIV (undectible RNA >1year), DM2, PAD w/ SFA stent (>1year ago in Munson), CABG and PCI (2013 and 2020 respectively), and dHF. He has had 2 recent admission in March 2023 where he went R+L heart cath and echo for chest pain, ultimately treated medically. Found to have cellulitis treated with 4 weeks linezolid. He comes from ED due to shock mostly hypovolemic and septic source so far suspected b/l LE.   Patient reports coming to emergency department 3/26 due to feeling "off".  He says he has had continued pain and drainage of his lower extremities that is not significantly worse.  Denies any other sources of infection (denies diarrhea, chest pain, palpitations, nausea vomiting, fevers, abdominal pain, cough, sputum production, shortness of breath, extremity swelling and pain).  Examination quickly found he was hypotensive requiring pressors with obvious open leg wounds (pictures charted).  He was given 2.5L of fluid resuscitation and was able to be weaned off pressor the following day while on the broad antibiotic coverage.  This also resolved his AKI and lactic acidosis. ID and wound/vascular are following.   Incidentally, patient was found to be COVID positive on 03/26.  He was started on remdesivir and steroids.   On 03/27 afternoon patient experienced severe chest pain.  Given his rising troponins, Cardiology was consulted for re-evaluation.  It was suspected that he had an ACS event of his circumflex artery.  He briefly had hypotension otherwise remained stable.  He was recommended 48 hours of heparin (stop date would be 3/30 8am).  The following night into this morning he has remained relatively asymptomatic and close to baseline.  He did have a slight increase in oxygen requirement following this event that has come down to 3 L NC. Workup during ACS event revealed some mild pulmonary edema. One dose of diuresis was given the only given his tenuous baseline with recent hypovolemic shock.  He otherwise was stable for transfer to floors for further management as mentioned in "recommendations at transfer" below."   Post ICU Course: - He was doing well. He suddenly had v.fib and collapsed while nursing in room. He was DNR/DNI. So chest compression or defibrillation was not done. He passed away on 3/29/2023 1711.
Had shots on Wed. 7/30; Mom didn't notice any problem til Thurs. PM at which time there was swelling and redness and fever at site. By next AM, swelling was down to elbow. No other symptoms. Was given Benadryl and Ibuprofen. "Okay" by Sat. or Sun.
Have not seen doctor or reported to my doctor but shivering early this morning around 5am to 6.30am, then sweating (mostly in the face), then stomach ache from 8.30am onward (currently 10.30am and still have stomach ache).  Also had sudden pain in both legs while in a cold cafeteria and had to bend over to endure it.  Lasted only a minute.
Patient was admitted fir chest pain and found to clinically as well as supported by Cardiac MRI have signs of myocarditis vs myopericarditis. Patient remained stable and did not require ICu admission, pressors, or emergent intervention. he was treated with NSAIDS and Colchicine and discharged with cardiac follow up and activity restriction to 1A activities.
Took flu shot at pharmacy and the next day could not get out of bed, fever my legs would not work I was forced to have my wife call ambulance. Admitted 3 days - advised no more flu shots.
I'm on a blood thinner; A spontaneous report was received from an eighty two-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and during vaccination he forgot to disclose that he was on blood thinner Eliquis.  The patient's medical history was not provided.   The patient received their first of two planned doses of mRNA-1273 (BATCH # 031M20A) on 10 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient stated I got my first dose of the Moderna vaccine today (10 Feb 2021). I forgot to tell them I'm on blood thinner. No further information was reported.  Treatment, action taken with RNA-1273 in response to the event  and the outcome of the event were was unknown.
Patient reported tingling in her feet bilaterally about 15 minutes after vaccine administration. Then noticed hives on shoulders and chest bilaterally. A rapid response was called and patient was found to be hypertensive (160s systolic) and tachycardic.
Patient received flu shot 11/3/14 5:30PM. Painful going in and hurt the night thru. Patient had difficulty moving arm across chest and range of motion was diminished without pain. Patient said is better than originally was but still hurts.