chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she received her first dose in March of this year and then developed COVID; she received her first dose in March of this year and then developed COVID; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on and unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Pharmacist stated that he had a patient who stated she received her first dose in March of this year and then developed COVID and that was why she had not been back to receive her second dose. She came back yesterday and did not have her vaccination card with her or any documentation proving that she was diagnosed with COVID. Pharmacist was not sure about her story and had not spoken with her doctor about it either. Stated that this patient did receive a second dose of the vaccine yesterday at his pharmacy. He was asking what was Pfizer input regarding longer intervals of dosing. Pharmacist states that the patient told the pharmacy staff she had not returned after her first dose of the Pfizer COVID-19 vaccine in March because she developed COVID-19. Caller states that the patient told his staff she waited this amount of time to receive her second dose of the Pfizer COVID-19 vaccine due to this diagnosis. Patient had not returned after her first dose of the Pfizer COVID-19 vaccine in March because she developed COVID-19. She waited this amount of time to receive her second dose of the Pfizer COVID-19 vaccine due to this diagnosis. Response to this was given as vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. Response regarding the efficacy of the COVID-19 vaccine was given as the second dose of Pfizer-BioNTech COVID-19 vaccine may be administered up to 6 weeks (42 days) after the first dose. Currently, only limited data are available on efficacy of mRNA COVID-19 vaccines administered beyond this window. Also informed the pharmacist that at this time antibody testing is not recommended as a means for testing immunity after vaccination. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
01/14/22 presents "as a transfer from outside hospital secondary to lethargy and altered mental status". PMHx of "normal pressure hydrocephalus status post VP shunt, psychosis, depression"
Patient had no known adverse effects after injection. Patient was underage, however authorization from legal guardian was given.
large red swollen area lt arm around inj site;no fever;12cm diameter area of erythema, induration & warmth around inj site; r/o cellulitis;rx DPH & ice call MD if swelling up or fever;swelling down on 9JUN96
nausea, vomiting for 3-5 days, intermittent diarrhea for one day  decreased appetite lethargy
Injection site left deltoid became red, swollen, warm, Tylenol prn for pain, ice packs, Pt also had HA. Mother state "fever" through temperature 98.5 when examined.
Diarrhoea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017CZIA) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL and THYROID (ARMOUR THYROID) for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-207535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up Information Received on 06-JUL-2021  contains No New Information.
Red, raised, nonvesicular rash appeared on left thigh at site of injection approximately 5-7 days after immunization administered. Rash was 3 hard bumps fixed under skin.  Rash cleared approximately 3 weeks after immunization administered. Pt developed fever up to 103 per rectum on 01/18/04.  Fever subsided by 01/19/04.
Fainted about 2 minutes after injection. Unconscious for about 1 minute. Called 911 and EMT checked patient and said appeared to be ok. Vitals were ok. Child was apprehensive before injection, but calmed down right after injection.
Myalgia, Arthralgia, Fever, Diarrhea, nasal drip,chills, Narrative:
Information has been received from a health professional concerning a 40 yr old male with drug hypersensitivity who on 19Oct04 was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fenofibrate (Tricor), warfarin sodium (Coumadin) and glyburide (+) metformin hydrochloride (Glucovance). On 19Oct04 the pt developed severe swelling and redness in his arm and left hand. The pt was seen at his doctor's office but no treatment was provided. Subsequently, the pt recovered from the severe swelling and redness in his arm and left hand. Additional information is not expected.
Systemic: Seizure-Mild, Additional Details: patient has seizure right after vaccine
Delayed injection site reaction, beginning approximately 9-10 days after vaccination was administered. Large bright red oval developed on arm near injection site. Hot and itchy.
neck hurt; feel like she is going to floor up; everything hurts; felt so weak; felling awful; all her body hurts; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (neck hurt), FEELING ABNORMAL (feel like she is going to floor up), PAIN (everything hurts), ASTHENIA (felt so weak) and MALAISE (felling awful) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (neck hurt), FEELING ABNORMAL (feel like she is going to floor up), PAIN (everything hurts), ASTHENIA (felt so weak), MALAISE (felling awful), MYALGIA (all her body hurts) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL DISCOMFORT (neck hurt), FEELING ABNORMAL (feel like she is going to floor up), PAIN (everything hurts), ASTHENIA (felt so weak), MALAISE (felling awful), MYALGIA (all her body hurts) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Moderna COVID-19 Vaccine EUA. Day 1 after injection: fever (100.4), constant headache, very sore at injection site,  general fatigue and muscle soreness. Day 2: woke at 3:00 am, all symptoms gone except sore arm. Day 3:  mild tenderness at injection site.
Hot flash; ringing in ear; Tinitus; hot flush; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flash), TINNITUS (ringing in ear), TINNITUS (Tinitus) and HOT FLUSH (hot flush) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2021, the patient experienced TINNITUS (Tinitus) and HOT FLUSH (hot flush). On 22-Jan-2021, the patient experienced HOT FLUSH (Hot flash) and TINNITUS (ringing in ear). At the time of the report, HOT FLUSH (Hot flash) and TINNITUS (ringing in ear) outcome was unknown and TINNITUS (Tinitus) and HOT FLUSH (hot flush) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) 3 days test nose swab.         No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up document contain new event  were added and patient demographics was updated.
Noticed when took off shoes at 8pm feet very itchy and blotchy. Rash spread and at 11pm broke out in hives. Went to ER given IV Benadryl and sent home with script he didn't fill. Uses 25mg Benadryl with relief till wears off. was on day 8 of Leavaquin prescription for diverticulosis which was stopped. Itching continues if doesn't take benadryl. Also had diarrhea x 5 days. Follow up 6/2004: No further information reported.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Chills. Narrative:
2-1/2" diameter raised red area on upper arm at injection site. Hot to touch, tender, firm, and complained of headache.
PATIENT STATES THAT HE FEELS LIKE HE HAS A "BLISTER" FROM HIS CHEST TO THE TOP OF HIS HEAD.  HE STATES THAT HIS FACE IS RED AND HOT
Johnson and Johnson vaccine given after 1st dose; 2nd dose missed; Johnson and Johnson vaccine given after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Johnson and Johnson vaccine as her second dose. No concomitant medications were reported. No treatment medication was reported.
No fever but chills, extreme fatigue, dizziness, and that was main thing. When I stood up the dizziness was overwhelming. I have never had chills like that before - ever. After I was back from vacation - on the 19th - I went to Urgent Care - I had a UTI - positive for that - had prednisone and antibiotic and I had it because later found out I had the kidney stones. Prior to that, on vacation, I had sun poisoning (rash) and dehydration and couldn't urinate on vacation - they gave me fluids at some Urgent Care don't remember the name, and gave cream for my skin and prior to vacation, I had shingles before I left. I had mild shingles at this time - because I knew to start the medicine. Was told I had a UTI and Pneumonia - they said I had a slight Pneumonia - I wasn't short of breath. Later on, I discovered I had a kidney stone - about a week and a half after - I went to my doctor and he told me to get a sonogram which I did. It has passed now. I'm just sore now. I had another sonogram but haven't had the results yet. Dr.
Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261).  About 3 hours after my second shot on 3/2/21, the room was spinning wildly to the point I could not look at the ceiling, I may have started to have "brain fog" that night as well.  3/3/21 I had chills, no fever.  3/4/21 while talking to a coworker I experienced a "neurological event", I felt like I received a flash software upgrade to my brain, and things "paused" for a short amount of time.  Later on 3/4/21 brain fog was significantly impacting me and it was hard to complete sentences and communicate effectively.  From 3/2/21 to 3/ 3/7/21 I experienced brain fog, fatigue, dizziness, and chills (no fever).  I was fine on 3/8/21.  All 4 side effects came back on 3/24/21.  I was having chills, no fever, early in the day then led a meeting in the early afternoon and could barely finish my briefing.  I was having issues with fatigue, some dizziness, and brain fog.  From 3/24/21 to 4/19/21 the side effects that mainly bothered me was dizziness/vertigo and some brain fog.  Majority of time throughout this period the side effects were sporadic.  I was able to function at 100% then wham, I was out of commission for 2-3 hours, then back to normal again for a multi-hour window.   Hydrochlorothiazide worked well.  I also took Meclizine with limited impacts.  Also took a prednisone pack that took the edge off.
nausea, vomiting, diarrhea, change in mental status, and generalized weakness about 36 hours from time of vaccine. Initially treated with supportive care. He returned 5 days later with continuing symptoms plus headache and was diagnosed with a intracerebral hemorrhage.
full body rash; hives, sparing the palms of my hands and soles of my feet; itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 20:00 (Lot number: FS1661) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE HYDROCHLORIDE; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL0140, administration time: 08:30 AM, vaccine location: Right arm), administration date: 22Dec2020, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: EL1283, administration time: 08:00 PM, vaccine location: Left arm), administration date: 12Jan2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "full body rash"; URTICARIA (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "hives, sparing the palms of my hands and soles of my feet"; PRURITUS (non-serious) with onset 08Jan2022 07:00, outcome "recovering", described as "itchy". The events "full body rash", "hives, sparing the palms of my hands and soles of my feet" and "itchy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus.  Additional Information: The patient had no known allergies. The facility where the patient received vaccination was reported as Pharmacy or Drug store. The patient received no other vaccine in four weeks. It was reported that, 16 days after receiving booster COVID vaccine, the patient developed a full body rash consistent with hives, sparing the palms of hands and soles of feet. Systemically fine and not to terribly itchy. The patient received Zyrtec as treatment for the events. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Initial and follow-up information has been received from a physician and a clinical manager concerning a 24 year old female with a history of pharyngitis streptococcal ("1 to 2 weeks prior to vaccination"), who on approximately 28-FEB-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 655327/1287U).  Concomitant therapy included hormonal contraceptives (unspecified).  The physician and case manager reported that "on the same day", approximately 28-FEB-2008, the patient "experienced pain and swelling at the injection site that lasted for 6 weeks."  The patient sought medical attention and was seen by the physician.  The physician and clinical manager reported that "the patient was followed-up today", 10-APR-2008, and the physician found signs of scarring and muscle necrosis.  The area was red, hard, and concave."  The patient had not improved.  The patient reported that she had an appointment with a plastic surgeon scheduled for 11-MAY-2008.  Additional information has been requested.
Achy upper right leg; Felt very much like the flu, felt sick; Got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy upper right leg), INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy upper right leg), INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick). At the time of the report, PAIN IN EXTREMITY (Achy upper right leg) had not resolved and INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient refused second dose. No concomitant medication details was reported. No treatment medication details was reported.
Vaccine error: Patient received an undiluted dose of new covid booster. (3 times the dose) Per parents, patient developed a fever and some soreness, slight decreased urine output, but remained "largely ok"
W/in 48 hrs p/immun pt experienced an inject site rxn which included swelling (size of baseball), redness, induration & hot to touch. Area was itchy. No spontaneous drainage; induration was nonfluctuant. Dx Cellulitis; Tx Keflex & Neosporin
Pain in injected arm 1 hour after administration with worsening pain over 24 hours, nausea, fever.
female presents to ED with complaint of Allergic reaction (Hives, swollen throat, SOB s/p 1st dose moderna COVID-19 vaccine. Given 0.6 IM epi @ site, 50mg IV benadryl + 500mL IVF. Janitor@ clinic) Patient is an employee at the clinic works as a janitor. Received her first dose of covid vaccine, then the moderna vaccine. Received this at 11 AM. At 2 PM started having shortness of breath and hives. At 2:30 she was treated at the clinic with epinephrine and Benadryl. Patient was transported to ER an hour and a half later. Patient get did get some IV fluids in route. Patient states that the hives are better no longer short of breath. Initially stated that her throat felt swollen and swallow now. No cough. No chest pain no abdominal pain. Patient has no prior history of allergic reactions. Patient discharged with prescriptions for Benadryl 25mg and Epipen JR 2-PAK.
my first two shots with no problems other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EN6202) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous", notes: Known allergies: Codeine based medication makes me, nauseous; Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous", notes: Known allergies: Codeine based medication makes me, nauseous. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "my first two shots with no problems other than a sore arm". The event "my first two shots with no problems other than a sore arm" was evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected. Additional Information: The patient reported that she got her first two shots with no problems other than a sore arm. When she got her booster, she got a fever; chills; body aches; nausea; sore, swollen glands; and a sore arm. She was not alarmed but figured it was an immune response. However, within the month she got shingles. She believed that had she not gotten this booster, she would not have gotten shingles. She believed people should be instructed to be vaccinated against the shingles prior to receiving this Covid vaccine. She wonder how many others this has happened to that have not reported it or thought there was a connection. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within 2 weeks. The patient did not have covid prior vaccination. The patient was not tested with covid post vaccination.
Tiredness began an hour after vaccine.  And about 10 hours later pain at the injection site.
Received DTAP, IPV, MMR, VARIVAX @ 12:08 PM on 10-19.  At 10:00 PM fever started and went up to 102.  Hives started on trunk, arms, feet.  Joint on pinky finger & pinky toe was swollen.  Pt was complaining of arm & leg pain.
Information has been received from a 80 year old female consumer with asthma who, 5 years ago, in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There were no concomitant medication. In 2002 the patient developed pneumonia and, again this spring. The patient indicated that she had not had pneumonia in 75 years and was surprised she developed it twice within 5 years of receiving the innoculation. She also reported that she was very sick, but not hospitalized because of this. Medical attention was sought, but no labs or diagnostic tests were done and no treatment was required. The patient recovered, but recovery date was not available. No product quality complaint was involved. The two episodes of pneumonia were considered to be life-threatening by the reporter. Additional information has been requested.
SHORTNESS OF BREATH; LITTLE CHEST PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, Laboratory data included: ECG (NR: not provided) normal, and X-ray (NR: not provided) normal. On an unspecified date, the subject experienced shortness of breath, and little chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and little chest pain was not reported. This report was non-serious.