chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin; received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin) and EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised). On an unknown date, the patient experienced RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin) and EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised) outcome was unknown.            No concomitant medication was reported.  It was reported patient in his 80s  Patient was not immunocompromised.   Treatment medication included 180 antihistamine   This case was linked to MOD-2022-566985 (Patient Link).   Reporter did not allow further contact
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 43-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FJ1620), at the age of 42, in left arm, on Nov 11, 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine, (batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history included mild hypertension (unspecified if ongoing) and dairy (unspecified if ongoing). Concomitant medications not reported. The patient experienced COVID-19/tested positive for COVID-19 (medically significant) and ineffective drug (medically significant), with outcome of not recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (May 8, 2022) negative; (Apr 30, 2021) positive, notes: Tested positive for COVID-19 on April 30. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. Clinical course: Patient did not receive other medication in 2 weeks of vaccination. No follow-up attempts possible. No further information expected.
Right arm at site started itching, was red and had slight swelling - this lasted 24 hours.
Cold sweats all night. The next day: fatigue, migraine, chills, dizziness, nausea.
88 y/o who developed right upper arm pain within 6 hours following receipt of Tdap and PNUEMOVAX vaccines in her right upper arm on 30 AUG 2012. Previous Td vaccine received on 27 JUN 2005 and previous pneumococcal vaccinations received on 26 NOV 2001 and 29 OCT 2007. Patient denies anything unusual about vaccine administration technique, and does not recall unusual pain during vaccine administration. Patient received vaccinations around 1030 on Thursday and by 1600, she experienced significant right upper arm and shoulder pain (8/10 on pain scale). The pain limited movement of her RUE; she drove home trying to use her left hand on the steering wheel. When she arrived home, she noted increased redness, swelling, and warmth surrounding vaccination sites (area about the size of a tennis ball). Patient denies any unusual or persistent bruising near vaccination sites. She took two TYLENOL 500 mg capsules before bed and tried applying CAPSAICIN to affected area, but still had difficulty sleeping due to the pain. In addition to pain and local reaction, patient was running a temperature of 100.1 on Friday and Saturday. On Friday, she felt her heart racing and she took ASA 400 mg. She attempted to call the clinic on Friday, 31 AUG, but due to training holiday, she was referred to the emergency room. She spoke to a nurse in the emergency room who recommended patient come in for evaluation, but patient declined. She was advised to apply warm, moist heat to the area and take TYLENOL as needed. (Patient reports she cannot take anti-inflammatories due to low platelet count). Patient followed advice and noted some improvement of right upper arm and shoulder pain by the following day; her heart rate returned to normal before bedtime on Friday. Patient had difficulty sleeping through the night Saturday and Sunday night due to pain. She noted increased pain with direct pressure to area and with movement of shoulder. (Patient reports history of right cuff tear). Patient denies weakness or numbness and tingling of upper extremities. She denies recent injury or trauma to right upper arm. Last p.m. patient took two TYLENOL 500 mg before bed and reports she was able to sleep through the night. Today her pain is minimal except with pressure to area and when holding arms at shoulder level in front of her. Patient was feeling well on the day of vaccine receipt. She denies any previous vaccine reactions. Patient denies any angioedema, rashes, respiratory, or GI symptoms.
On 11/9/2021 I started to have pain across my chest, back and around the area that the vaccine was given. I had quite extreme pain in the center of my chest around the sternum which made it painful to breathe. My armpits started to swell, and my fever increased to 104 degrees. The pain increased as well in my chest and back. The fever subsided to 101 degrees. I took medicine to ease the pain. The next morning, I still had a temp of 101 degrees. My armpit was severely swollen. The chest and armpit were very painful. I couldn't close my arm all the way. On 11/11/2021 the chest pain eased, and my armpit was still swollen. On 11/12/2021 my armpit went down. Then on 11/13/2021 it went down halfway. On 11/14/2021 my armpit went down all the way. The armpit was tender to the touch for 7 days after getting the vaccine. On 11/9/2021 I also had severe migraines that lasted for a month. The migraines I had were managed before taking the vaccine, but after getting the vaccine they came back. It took a month to manage them again. I went to a neurologist, and they prescribed a new medication for me that is managing my migraines now.
Welts on both side of thighs, in crease of left arm; Rash below site of injection; "a little bump" below site of injection, swelling below injection site; Itching below site of injection on bump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching below site of injection on bump), URTICARIA (Welts on both side of thighs, in crease of left arm), INJECTION SITE RASH (Rash below site of injection) and INJECTION SITE SWELLING ("a little bump" below site of injection, swelling below injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, SIMVASTATIN, ATENOLOL, IRBESARTAN, VITAMIN C [ASCORBIC ACID], PYRIDOXINE HYDROCHLORIDE (VITAMIN B 6) and VITAMIN B3 for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (Itching below site of injection on bump) and INJECTION SITE SWELLING ("a little bump" below site of injection, swelling below injection site). On 13-Feb-2021, the patient experienced INJECTION SITE RASH (Rash below site of injection). On 21-Feb-2021, the patient experienced URTICARIA (Welts on both side of thighs, in crease of left arm). At the time of the report, PRURITUS (Itching below site of injection on bump), URTICARIA (Welts on both side of thighs, in crease of left arm), INJECTION SITE RASH (Rash below site of injection) and INJECTION SITE SWELLING ("a little bump" below site of injection, swelling below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 22-Feb-2021, the patient went to urgent Care and was prescribed prednisone. The patient was started on Allegra and Triamcinolone cream but she did not use the medications.
FEVER 103 1HR AFTER VACCINE GIVEN, BODY RASH X3 DAYS WITH FEVER. FEVER CONTROL WITH MOTRIN AND TYLENOL. FOLLOWUP VISIT ON 5/11/11 NO FEVER, BABY HAPPY AND EATING.
positive pregnancy test on 3/11/21. symptoms started before 3/11/21, pt started to bleeding before 3/18/21.  pt is sonographer she had an idea of ectopic pregnancy, pt went in for bhg for first quant on 3/15/21  and again on 3/17/21.  bleeding increased on 3/18/21 passing clots and cramping.  quants decreased, pt came to office for ov to assess us preformed and pt then sent to er for eval.  determined to have ectopic pregnancy.
------------------------------------------------------------------------------------- CLINICAL NOTE FOR  ------------------------------------------------------------------------------------- Patient came  in for second Moderna COVID 19 vaccine. She reported and had  pictures of hives and itchiness  on her phone that developed 5days after the vaccine . She had the vaccine on 3/12/2021 and the hive developed on 3/17/2021 as dated on her picture. She took  one dose of Allergy Relief on the second day and reported she had relief from the hives and itchiness within acouple of hours.  Patient stated she had not eaten or used anything out of the ordinary after the vaccin
p/vax pt devel chickenpox w/20-30 vesicular eruptions on pt trunk, extremities & face;6/19/98 pt had a total of more than 100 vesicular eruptions;
The first day site started itching by day three developed little pus filled bumps. Continued to cover those areas, started running fevers of about 101.4 to 102.3 along with several headaches. Day nine became sore in mid axillary area on day ten patient states she swelled enough that she couldn't wear a bra. On day 11 site turned red with several red streaks across chest.
Fever (Oral 101.9F at home), fatigue, malaise, headache with lightheadedness and a mild sore throat.
PAIN, REDNESS AND SWELLING NEAR INJECTION SITE, BODY ACHES ,UPSET STOMACH, DIARRHEA, FEVER STARTED APPROXIMATELY 14 HOURS AFTER VACCINATION.  FEVER WAS BETWEEN 101 AND 102 FOR 3 DAYS.  STOMACH UPSET AND DIARRHEA STILL CURRENT ON DAY 6 POST VACCINATION.   REDNESS AND SWELLING NEAR INJECTION SITE STILL PRESENT DAY 6 POST VACCINATION.
This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age and ethnicity received PREVNAR 13, (NDC number: 005197102, Lot S31257, Expiry Date Jul2018), via an unspecified route of administration on 20Oct2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness at injection site which was about 3 inches wide and the vaccine site was swollen on an unspecified date in 2017 with outcome of unknown. It was not tender to touch and the patient did not have any other symptoms.
Chills; needed a blanket to sleep in near-80 degree weather. Woke at 6:00 AM on 09/29/2011 with a fever of 100 degrees, headache, and nausea. Able to keep down ginger ale. Vomitted coke at 1:30 PM on 09/29/2011.  Stayed in bed.  Recovered by 6:00 PM on 09/29/2011.
Patient c/o feeling tired and ill starting 6 hours after the dose was administered, she also developed a fever to 101.5F that responded to antipyretics and lasted approx 48 hours (AF in the last 12 hours).    She also developed a local reaction on her left upper arm that appears red and feels warm to touch and extends 6.5" down from the shoulder and 3.5" from side to side.   She has not treated the area in any way.  There is a darker red area at the injection site, not raised.   Recommended that patient applies cool compresses to the area and uses a nonsedating histamine.  If reaction getting worse or not improving, she should also seek MD evaluation.
fell sick; was positive for covid; was positive for covid; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. A 64 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date the patient fell sick and was positive for covid on 16Feb2021. The reporter was concerned about when is the right time to receive the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Feb2021. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out
When vaccination was administered, liquid leaked out of the needle resulting in a full dose not being administered; Administered liquid leaked out of the needle; Vaccine administered to pregnant patient; A spontaneous report was received from a pharmacist concerning a 32-year old pregnant female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced vaccine underdose, device connection issue and vaccine exposure during pregnancy.   The patient's medical history was not provided. No concomitant product use was reported.  On 02-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. When vaccination was administered, liquid leaked out of the needle resulting in a full dose not being administered. It was unsure if less than half of the dose was administered.  No treatment for the events was reported.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcomes of the events, vaccine underdose, device connection issue and vaccine exposure during pregnancy, were considered recovered/resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure during pregnancy for mRNA-1273, lot #013M20A with no associated AEs.
Well, that's interesting. I just recently was diagnosed with bleeding in the lining of my stomach; I have a huge lump in my arm for about three four days; The redness is fading but it''s spreading and it''s like about it''s like big rectangle on my arm is about two and half inches wide, about four and half inches long.; I did experiences a big rash.; It was a great big circle and it itched and it itched and it itched .; Booster Pfizer; Booster Pfizer; This is a spontaneous report from a contactable consumer (Patient). A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Oct2021 (at the age of 87-year-old) (Lot Number: FF8839) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included cyanocobalamin (VITAMIN B12); donepezil; furosemide; hydralazine; labetalol; losartan, all taken for an unspecified indication, start and stop date were not reported; levothyroxine; tolterodine, all taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 1 (BOOSTER), SINGLE and on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 2, SINGLE for COVID-19 immunization. On 06Oct2021, the patient had a huge lump in arm for about three four days and also had accompanied with the big red rash; it was a great big circle and that it itched. Since then the patient had been applying an anti-itch lotion to it and like an anti-itch cream. The redness was fading but it was spreading and it was like big rectangle on arm was and was about two and half inches wide, and about four and half inches long. It doesn't itch much but it still was itching. The patient was diagnosed with bleeding in the lining of her stomach and received pantoprazole 20 mg once a day for bleeding in the lining of my stomach and aspirin 81 mg once a day. The outcome of the events bleeding in the lining of stomach, huge lump in arm and rash was unknown. The outcome of events redness, and itching was recovering.  Follow-up attempts are completed. No further information is expected.
3/19/2021-3/22/2021 sore stiff shoulder. I was constantly stretching my arm (frozen shoulder) daily Cant attach sheets
Chills, fatigue, fever, extreme muscle aches,  headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm.  The following day my body hurt, headache, mild nausea.  Still have pain in lymph node under vaccinated arm and arm muscle twitch.  Mild dehydration.
Sore arm within a few hours of injection and lasted 5 days, swelling and puffiness at and around the site lasted 3 days, ran a high fever during the first night and finally broke on the 3rd.  Highest known temp 104.  On the 24th, had body, muscle and joint pain and felt like I had the flu for 2 days.  Since the 24th, I've been extremely tired and no energy.
Patient states he broke out in a rash about a week after receiving the flu vaccine, saw his physician for bloodwork, and they couldn't figure out what was going on, so he was referred to a dermatologist as rash turned into pus-filled pimples.
Per pt report, she experience a knots at injection after administration which she rubs to prevent it from getting worse. Pt contacted me on 11/10 to let me know that her arms was hurting and she experienced tender at injection site 7 days later, per pt knots disappear but her arm is still tender and difficult for her to freely move her arm.
On 9/7/21I awoke with pain in both legs and when I got out of bed, my legs were weak and hypotonic. Even when contracting, they were very soft and flaccid. I exercise daily and usually have excellent leg tone and strength. The pain worsened throughout the day and involved both quadriceps groups.  Patella tendons were tender bilaterally. There was a subjective low grade fever; however, I did not take my temperature. there was also  strange mild  left sided parietal headache. There was also some strange sensation in my upper arms bilaterally. I suspected this was some variant of Guillian Barre syndrome. sine there is no treatment, I decided to monitor it and not seek medical treatment unless it began to ascend.  The arm symptoms resolved within 2 hours. After approximately 12 hours there was some return of strength in my legs but the were not at baseline. By 7AM on 9/8/21, the leg pain had resolved and strength was near baseline. The headache persisted throughout the day.  On 9/9/21 I felt normal upon awakening. I went to the gym and did a partial workout but I did not have my usual leg strength. On 9/10/21 I was able to complete a normal workout.
A rash that I've got all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash that I've got all over my body) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (A rash that I've got all over my body). On 25-Feb-2021, RASH (A rash that I've got all over my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
pt recv vax 9MAY97 & 10MAY97 began to exp myalgias, arthralgias, fatigue, irritability & ecchymoses;seen by MD 1wk post vax for esophageal burning reflux;6JUN c/o lt sided chest pain MD felt was costochondritis;