chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fevers; chills; fatigue; body aches; headache; diarrhea; loss of apetite; severe inability to focus -brain fog; severe inability to focus -brain fog; This is a spontaneous report from a contactable other hcp (Patient). A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, (Batch/Lot Number: EN6206)), via an unspecified route of administration, administered in the left arm on 02Apr2021(age the time of vaccination was 42-year-old) as dose 2, 0.3 ML Single for COVID-19 immunisation. The patient's medical history included asthma, migraine, urinary tract infection, bronchitis, pneumonia. The patient's concomitant medications were not reported. The patient previously took sulphonamide and experienced drug hypersensitivity. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE solution for injection, Lot number: ER8733) in left arm on12Mar2021 at 10:00 AM (age the time of vaccination was 42-year-old) as dose 1, 0.3 ML Single for COVID-19 immunisation. Patient Received 1st dose 12Mar2021 by late that evening and by 13Mar2021 unable to get out of bed, fever 100F, chills, body aches, difficulty breathing, chest tightness, and abdominal pain. on 15Mar2021 difficulty breathing, flu-like symptoms and given an injection of steroids and CX Ray 17Mar2021 done. Symptoms continued to worsen with increasing difficulty to breathe, gasping for air, 02 stats were btw 88-93 for 3 weeks. Had several telehealth appt w/ pulmonologist. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. Fevers persisted for about the last two months. On an unspecified date, the patient had fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 16Apr2021 Blood test. Therapeutic measures were taken as a result of fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog, severe inability to focus -brain fog. As treatment medication Pre and post dosing of prednisone and Tylenol with little to no relief of symptoms. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
a large majority of vaccine squirted out of the needle; not sure if she received the full dose; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (a large majority of vaccine squirted out of the needle) and INCORRECT DOSE ADMINISTERED (not sure if she received the full dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 15-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (a large majority of vaccine squirted out of the needle) and INCORRECT DOSE ADMINISTERED (not sure if she received the full dose). At the time of the report, DEVICE CONNECTION ISSUE (a large majority of vaccine squirted out of the needle) and INCORRECT DOSE ADMINISTERED (not sure if she received the full dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
The rash began with a red and inflamed bump on my arm. The bump became to be really itchy and even more inflamed. I have had the bump for about two days now.
BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. 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: Unknown) 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 APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs.  On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.
Left tympanic pain, tinnitus both ears, sound in ears. Headache, menstrual problems.
I had no issues before the shot.  After I took the shot, I developed a rash on my stomach the next day. I did not pay attention and I thought it was the rash they were talking about.   It started to hurt the next day and was still red and not getting better.  I went to urgent care and I told them that I took the COVID-19 shot.  They said that I had shingles.
Fever for 2 days at 100.2 Muscle and joint pain. Headache. Redness and warmth near injection site. Painful arm for first 12 hours. On second day, onset of digestive issues including diarrhea.
soreness; headache; bilateral hamstring muscle pain; This is spontaneous report from a contactable other Health Care Professional via Pfizer sponsored program. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 26Jan2021, as a single for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 05Jan2021, as a single for COVID-19 immunization. The patient's medical history included Chronic Lymphocytic Leukemia and some particular type of anemia. She received IVIG treatment every 30-32 days. Concomitant medications included Intravenous Immunoglobulin (IVIG) treatment every 30-32 days. On an unknown date, the patient experienced bilateral hamstring muscle pain, soreness and headache. On 26Feb2021, the patient underwent blood test to detect antibodies against COVID infection and the result was negative. The Reporter wanted to know what are all the other tests they can do and also stated that he heard that muscle pain has been reported 38% post vaccination. He wanted to know if muscle pain can progress to myalgia. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. It was reported that antibodies in some persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, Immunoglobulin M and Immunoglobulin G antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection was not known. It was also important to note that some persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected. The outcome of the events was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested.
carpel tunnel in her shoulders; the "normal" aches; swelling on her shoulders; muscles are still very sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), PAIN (the "normal" aches), SWELLING (swelling on her shoulders), MYALGIA (muscles are still very sore) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), PAIN (the "normal" aches), SWELLING (swelling on her shoulders), MYALGIA (muscles are still very sore) and PYREXIA (Fever). On 12-Feb-2021, PAIN (the "normal" aches) outcome was unknown, PYREXIA (Fever) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (carpel tunnel in her shoulders), SWELLING (swelling on her shoulders) and MYALGIA (muscles are still very sore) outcome was unknown.            No concomitant medication were not provided Patient underwent treatment medication of Steroid shot   This case was linked to MOD21-14950, MOD21-15037 (E2B Linked Report).; Sender's Comments:  MOD21-14950:1st dose of vaccine MOD21-15037:1st dose of vaccine
On 2/19/15, patient states she, "passed out at work after having injured fingers." States she took her BP at home and it was low, unsure of exact reading. On 2/11/15 she woke up with raised rash covering arms, trunk, legs, and it was scattered in her face. Followed up on 2/17/15 and she said took BENADRYL for 2 nights and rash completely resolved.
Headache and flu-like symptoms in mid-April, 2001. Went to ER on 4/22/01 and was unable to stand on her own. On 4/24/01, went to ICU on vent. Transferred to another hospital with a dx of Leukemia (AML). Life expectancy unknown. The annual follow up received on 5/29/03 states pt died summer 2002.
This case was reported by a healthcare professional and described the occurrence of hepatitis A antibody negative in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). At an unknown time after vaccination with TWINRIX, the subject experienced hepatitis A antibody negative. The subject's titres were drawn and revealed no titres for hepatitis A. No further information was provided.
I have shoulder pain from my vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ARTHRALGIA (non-serious), outcome "unknown", described as "I have shoulder pain from my vaccine".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Fully vaccinated, not boosted.  COVID infection breakthrough with inpatient hospital stay in ICU.  Immunocompetent
pt recvd 1st dose of Hep B vax on 13JAN92; w/in 2 to 4 hrs the pt devel 3 to 4 tender papular-like lesions on both areolar area burning pain in nipple area; sx persisted for approx 8 days; pt recvd 2nd dose & w/in 24 hrs sx had recurred;
From her allergist"...since her 2nd COVID vaccination.  Within an hour of the shot she felt nauseous and had flushing.  She responded to antihstaimines initally but then at 24 hours developed flushing, redness, shaking.  Her HR and BP were elevated.  Her throat felt tight and she was getting worse despite antihistamines and used her Epipen.  Went to ED and given bendaryl, ativan, solumedrol.  She felt better and was discharged home.  Yesterday she had another bad flare but was feeling better today.  Took 60mg prednisone on Sunday and 50mg this AM.   After her Xolair she had a significant flare.  She felt her whole body flushing and she developed hives and itching.  Her voice changed and her throat was tight and she was given epi x2.  Also took 50mg of hydroxyzine and was given IV benadryl.  She was taken to the ED.  I spoke with the ED doctor at 4:30 and she seemed to be better.  She was given pepsid as well as zofran and ativan.  I spoke with her at 5:45 and she sounded like she was not feeling better.  Her voice was froggy and she reported that she did not feel like things were calming down. I spoke with the ED again and asked them to give her another 50mg of hydroxyzine and if still not improving solumedrol.   I do think this is in the setting of her vaccination causing an immune stimulation and not related to the Xolair.  We discussed that the Xolair should help but may not be immediate.  She was to continue tapering steroids to 40mg tomorrow but she should take 60mg if still symptomatic.  I asked them to keep her at the hospital until she has significantly improved..."
2 hrs. after vaccine pt states pain constant 10/10 w/shooting pain, swelling, and decreased ROM.
I had a persistent cough that has lasted me for 2 months, it is productive. It is not producing any blood, but I have been coughing up 1x2 centimeter size phlegm from my lungs. I have lost my sense of smell at the end of February until March 5, 2023. I have been given benzonatate, but it has not helped the cough at all. I was sent for a CT scan, I am waiting on the results, I was also sent for a pulmonary function test. I have the results, but I cannot decipher what it means so I will have to wait on the doctor.
Pt reported arm pain before Thanksgiving. I checked with her today if still had arm pain due to flu shot. She did. Pt will contact me in next 24 hours with her primary care doctors information..doctors on file are immediate care providers. Pt did not have primary care MD info available when asked today. Per Pt arm pain significant enough to warrant MD visit.
Red rash on back, arms and legs. 101.2 oral temperature. Joint pain, bruising
Information has been received from a physician concerning a 26 year old female who  was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. The next day the patient developed two coin-shaped lesions on one arm and one on the other. These lesions were raised and erythematous, but not pruritic. The patient sought unspecified medical attention. Follow up info indicated that subsequently, the patient's symptoms resolved without treatment. Additional follow up info indicated the patient subsequently received a second dose of Hepatitis B vaccine recombinant without an adverse reaction.
Hives all around arm and red. MD prescribed levquin tables-500mg for swollen and infected area.
Information has been received from a registered nurse concerning a 74 year old male patient who on 30-APR-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot number: 672781/1706AA, dose and route not reported). On 01-MAY-2012, the patient started experiencing fever and around injection site, there was a patch of redness that was about size of "2 by 5 inches". The patient sought medical attention by visiting the office. He was treated with "antibiotics" (unspecified). No lab diagnostics studies were performed. At the time of the report the patient did not recovered. Follow up information has been received from the registered nurse concerning the 74 year old male patient with none medical history who on 30-APR-2012 was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot number: 672781/1706AA) on left arm. On 02-MAY-2012 the patient experienced left arm swollen and red and low grade fever. Cephalexin and TYLENOL were given respectively for the AE. The patient was recovered on an unspecified date. No information is expected.
He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant medications were reported.   It was reported that, when the patient was getting his booster shot, the person giving the dose to him said that something fell off and she scrambled. He thought the needle fell from the syringe. The patient was not sure if he got the appropriate dose. The patient had no side effects and he was fine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642850:Crosslinked with case (Wife case)
Patient stated that she had swelling and erythema extending the whole area of the left upper arm and some itching.
Vaccine given was past beyond use time.  Vial was mixed at 7:50am and dose was administered at 3:40pm ~8 hours after mixing (should have been discarded at 6 hours)
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. The nurse reported that the 5 improperly stored doses of VAQTA (lot# K005958, expiration date: 09-FEB-2017) were inadvertently administered on the following dates: 17-APR-2015, 27-APR-2015, two doses were administered on 29-APR-2015 and 26-MAY-2015 (route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected, the reporter does not wish to be contacted.
Body aches and sore arm the next day (R) arm became red, hot to touch (next day) pt had HA and fatigue. Saw MD and received 7 day course of cephalexin 500 mg QID on 10/22/13.
Pt received IPV and MMR in left leg on 08/07/2000. Both appeared red and with mild swelling within 26 hours.
Approx 15-20 seconds post injection pt stated she became flushed, diaphoretic and weak. Pt states she felt as if she could not take a deep breath. Pt temp 99 deg F. Pt feet elevated. BP 90/60, Pulse 83.Pt given orange juice and graham crackers and Tylenol 325 mg. After approx 15 min, pt verbalized she felt better. BP 110/60, pulse 83. Pt was pale, but color returned after 15 minutes. Blood Glucose 115. Pt was able to stand without difficulty and walk. Total time 20 minutes.
Pulmonary Embolism RLL Dyspnea and RUQ pain started @ 6 days prior (4/8/2021) to hospital admission on 4/14/2021.  Went to hospital secondary to n/v/RUQ pain and was found to have choledocholithiasis.  Due to dyspnea, CTA was performed with positive PE.  PE was felt to be present on admission.   Of note, patient was also found to have a lung mass on the Left upper lobe.  Mass has grown from prior CT scans and is considered suspicious.  Plan for pulmonology f/u and PET scan is pending.
Shot was a good shot and no complications to slight headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Shot was a good shot and no complications to slight headaches) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Shot was a good shot and no complications to slight headaches). At the time of the report, HEADACHE (Shot was a good shot and no complications to slight headaches) outcome was unknown.            No treatment details were reported. Concomitant medication were not reported
Woke up with itching on hands at 3:30 AM. Went back to sleep and woke at 5:30 AM with red rash all over my arms, chest, stomach, under arms. By 9:00 AM, had spread to scalp and face. Called my doctor and they are to call in a steroid pack.
Left arm-swollen from shoulder into hand. No erythema no bruising at injection site. Vaque tenderness to palpation all over. Full supperation, promation, extension, and flexion.
Oth complications following immunization, NEC, init on 2017-11-14.
Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage.  The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins.  On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported.  On 19th Jan 2021, her hCG levels started to climb back up again.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration.  The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable