chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; extreme left arm pain; extreme fatigue; uncontrolled shaking on exertion; lack of appetite; patient received 3rd dose of vaccine; patient received 3rd dose of vaccine; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 29-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on 20Aug2021 at 16:45 (at the age of 29-year-old) as a dose 3, single for COVID-19 immunization. The patient's medical history included ulcerative colitis, autoimmune disease, other medical history: other autoimmune disease (undetermined), known allergies Latex. Past drug event included meclizine and experienced known allergies meclizine, known allergies Latex, meclizine. The patient's concomitant medications in two weeks included vedolizumab (ENTYVIO), methotrexate, prednisone, all were taken for an unspecified indication and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks was reported. No covid prior vaccination and covid tested post vaccination was reported as yes. Covid test type post vaccination was Nasal Swab. On 20Aug2021 at 20:00, the patient experienced possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. Treatment was not received for the events possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite. On 13Aug2021, the patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test), resulted as negative. The outcome of the events for possible low grade fever, extreme left arm pain, extreme fatigue, uncontrolled shaking on exertion, lack of appetite was not recovered while for the other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the third dose of GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. The patient was administered the third dose of GARDASIL 4 weeks after the second dose of GARDASIL. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Lips swelling, cough, hives treatment epinephrine sub q 1:1000 went home stable.
I experienced bad chest pains, flu like symptoms and was really hard to take my daily activities. I had a telehealth appointment the day I went to the ER to check my heart. They performed EKG, chest x-rays and everything was normal. They could not explain to me why I had those symptoms. I was told to take Ibuprofen 400mg a daily for about one week to help relieve the pain.  I also got an inhaler of albuterol that I now use intermittently if I get chest pain.  I do not have my lot number to provide
Patient presented with a fever, confusion, and had an altered mental state. Patient is fully vaccinated and resulted positive.
Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.
My son was given his 1st vaccine on 2/1/21. He had no reactions or  problems. He was scheduled to receive his 2nd dose on 2/25/21 but due to the ice/snow storm in Texas it was postponed until 3/4/21. When he presented at the vaccine hub for his appointment they refused to given him the vaccine.
Patient with history of syncope with blood draws experienced syncope within several seconds of dose 2. She recovered within seconds and was monitored for 30 minutes and demonstrated a return to baseline.
leg cramps started evening of around 10/22/23 and still occur periodically, insomnia started around 10/29/23 and improved around 11/12/23, anxiety started around 11/5/23 and resolved around 11/11/23, elevated blood pressure 11/8/23-11/9/23 seems resolved, extreme drowsiness 11/5/23-11/10/23, unsteadiness and weakness 10/22/23 improved by 11/12/23, intermittent headache 11/7/23 resolved 11/6/23.
I lost my taste. This has been going for about a year now.  I have a little of my taste back but I have not fully recovered. I went to my doctor about this last spring.  They did blood test, shows that I have a vitamin b12 deficiency.
On second day woke up with red rash on my face (no where else).; Next morning felt like every bone was broken in entire body; Acheyness started 6 hours after shot; 101 fever for 24 hours; On day 3 of diarrehea, violently threw up for 24 hours (pulled muscle in shoulder and sore ribs); On day 3 of diarrehea, violently threw up for 24 hours; Pulled muscle in shoulder and sore ribs; Pulled muscle in shoulder and sore ribs; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), allergy to intravenous pyelogram (IVP) dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (Z-PAK) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Apr2021 at 17:00, 6 hours after shot the patient experienced acheyness. On 29Apr2021, next morning the patient felt like every bone was broken in entire body. On Apr2021, the patient experienced 101 fever for 24 hours, on day 3 of diarrhea, violently threw up for 24 hours (pulled muscle in shoulder and sore ribs). On 30Apr2021, on second day woke up with red rash on my face (no where else). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 101 (units unspecified) fever for 24 hours was resolved on Apr2021, while that of the event violently threw up for 24 hours was resolved on an unknown date in Apr2021. The clinical outcome of the events achiness started 6 hours after shot, next morning felt like every bone was broken in entire body, on second day woke up with red rash on face and no where else and on day 3 of diarrhea, and pulled muscle in shoulder and sore ribs was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Soon afterwards, I was bradycardic and I went to hospital and they put a pacemaker in. Unsure of exact dates, probably weeks later. It wasn't right away. I had problems before I went in which was a weird heartbeat and high blood pressure. I was hospitalized at Hospital for a couple of days. I still have shortness of breath.
Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Positive for covid between the first and the second dose; A spontaneous report was received from a consumer concerning a 60-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for COVID between first and second.  The patient's medical history was not provided. Concomitant medications were listed as meloxicam, allopurinol, rosuvastatin calcium, acetylsalicylic acid and vitamins nos.  On 05 Jan 2021, approximately 10 days prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 027L20A) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, patient tested positive for COVID-19.  Treatment information was not provided. Lab tests mention a positive COVID-19 test.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, tested positive between the first and second, was considered resolved on 14 Jan 2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6201), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Nov2021 at 13:00 as dose 3 (booster) , single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TAVR" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Pleuralefusion" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: Apr2019, stop date: 27May2022; LOSARTAN, start date: 21Nov2021, stop date: 27May2022; HYDROCHLOROTHIAZID, start date: Jun2010, stop date: 27May2022; HYDROXYCHLOROQUINE, start date: Jun2005, stop date: 27May2022; PREDNISONE, start date: May2001, stop date: 27May2022; ASPIRIN 81, start date: Aug2001, stop date: 27May2022; NEXIUM [ESOMEPRAZOLE SODIUM], start date: Aug2010, stop date: 27May2022; RED YEAST RICE, start date: Sep2018, stop date: 27May2022; FLAXSEED OIL [LINUM USITATISSIMUM OIL], start date: Oct2009, stop date: 27May2022; PROBIOTICS, start date: Mar2018, stop date: 27May2022; VITAMIN C [ASCORBIC ACID], start date: Jan2015, stop date: 27May2022; VITAMIN B-12, start date: Jan2010, stop date: 27May2022; VITAMIN D NOS, start date: Jan2010, stop date: 27May2022; TUMS ULTRA, start date: Nov2020, stop date: 27May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 8-10 hours after administration I developed sore throat.  This progressed with swelling on right side of throat and uvula.  It progressed over the next 5 days where I was essentially unable to eat or talk.  I do not think this was a coincidental viral infection as I am retired and have minimal exposure especially with the Covid precautions .  Also ,none of the family members were affected.   Today is exactly 1 week since the vaccine and it is the first day I was able to feel close to normal and without fever.  I still have significant swelling and pain in the right side of uvula and posterior aspect of the throat.
Report received from a consumer on 11-OCT-2010 (received via Merck WAES: 1010USA01212). An 83 year old female patient received one dose of Influenza vaccine (brand unknown, batch number: unknown, expiry date: unknown, route of administration: not specified) in the left arm for immunisation on an unspecified date. The patient has a medical history of hypertension, mild arthritis and had a left hip replacement in September 2010. Concomitant medications included lisinopril and CELEBREX. Dose/ route of administration and indications of concomitant medication not specified. On an unspecified date, after receiving influenza vaccination with the suspect drug, the patient developed swelling and a 'knot' in her lower left leg. The patient sought medical attention. She was evaluated in the emergency room and diagnosed with an infection in her left leg. The patient was treated with ciprofloxacin (manufacturer unknown). X-rays of her left leg was negative for blood clot. The patient's outcome was recovering at the time of reporting. No other information is available at this time. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
This spontaneous report as received from a health professional refers to a patient of unknown age. On 08-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M035146 that expired on 26-JUL-2017. No adverse effects reported.
At first, cold chills, then hot, then headache in back of neck, then sinus involvement, then headache in front of head, and major lethargy for the next 24 hours.
Experienced difficulty breathing, severe wheezing, hoarseness, elevated heart rate, dizziness, hives, paleness and weakness.  I went to the emergency room and received 2 steroids, 2 benadryl and a breathing treatment.  Went home with an inhaler and benadryl.
Developed Red Swollen area around injection site that is approximately 4 inches x 6 inches. Did not start until following morning. Saw doctor was given Prednisone and Hydrocortisone topical.
I had the typical post-vaccine soreness for 2 days but the pain persisted after that and was made worse by certain motions that involved raising my arm or by laying on my left side. I also have limited range of motion and have been developing back pain on my left side. It has been over a year and I still have pain on a daily basis. Diagnosis by orthopedist is SIRVA
The neck and down into shoulder blade is like it hurts; The neck and down into shoulder blade is like it hurts; This is a spontaneous report from a contactable consumer or other non healthcare professional(Wife). A 68-year old female patient received bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:00  as DOSE 2, SINGLE for covid-19 immunisation and patient previously received bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported.The neck and down into shoulder blade is like it hurts: The wife states her side effect just started the day before yesterday, 15May2021, on the right side which is the last side the caller received second dose Pfizer Covid Vaccine on.  The wife's neck and down into her shoulder blade is like it hurts.  The wife states this is persisting.  If she puts a heating pad on high and lays down, it will feel like it goes away but as soon as the heat cools off the hurt is right back. The patient experienced pain in the neck and down into shoulder blade that hurts from 15May2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected..
Approximately 5 minutes after getting flu vaccine 10/17, he developed numbness, tingling sensation lateral to nose bilaterally. No weakness, rashes, itching or pain. 10/22 he also had numbness thoracic back, now resolved. Vomited x 1 on 10/22.
When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 17Mar2023, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Mar2023 as dose 1, 0.5 ml single (Lot number: FY2475) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious) with onset 03Mar2023, outcome "unknown", described as "When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective". Additional information: There was actually no vaccination to a patient. When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective. The reporter was just looking at getting the product replaced.
COVID arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002537) for COVID-19 vaccination.     Concomitant products included MIRTAZAPINE (REMERON) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was received for the event experienced by the patient.  Patient stated that the reaction lasted up until the second dose of vaccine.   This case was linked to MOD-2021-231049 (Patient Link).
I have three large oval shape red spots on my skin.  One is above my right breast, one is under my left arm and one is on my left hip.  I went to the dermatologist not know what it was.
She developed a small scab at injection site. Its lasted 2 weeks. Scab shows no sign of infection. Told her to follow up with PCP.
pt recv 2nd dose of vax;exp redness at inject site;devel yellowish discoloration in the whites of eyes;tired;
Staring spells noted 11/11/09. Loose stools and few episodes of vomiting starting 11/11/09. Abnormal movements noted 11/14/09. Infantile spasms diagnosed 11/17/09.
On that Saturday morning I developed an abrupt onset headache. I decided to lay down. I took my blood pressure of 230/30, and I went to the ER. They did an MRI in the ER to rule out a bleed. I was discharged after my blood pressure went down. The next day my blood pressure went back up. I did go back to the ER, and they just monitored me and then I was discharged after that. The next few weeks I did not have any more problems with my blood pressure.
headache; congested sinuses; lack of sleep; tiredness/ fatigue/ feeling very tired; sore right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/ fatigue/ feeling very tired), PAIN IN EXTREMITY (sore right arm), INSOMNIA (lack of sleep), HEADACHE (headache) and SINUS CONGESTION (congested sinuses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (tiredness/ fatigue/ feeling very tired) and PAIN IN EXTREMITY (sore right arm). On 14-Apr-2021, the patient experienced INSOMNIA (lack of sleep). On 15-Apr-2021, the patient experienced HEADACHE (headache) and SINUS CONGESTION (congested sinuses). On 17-Mar-2021, FATIGUE (tiredness/ fatigue/ feeling very tired) and PAIN IN EXTREMITY (sore right arm) had resolved. At the time of the report, INSOMNIA (lack of sleep), HEADACHE (headache) and SINUS CONGESTION (congested sinuses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or medical history provided.
Patient received dose on 10/21/22, this lot had an updated/changed expiration date of 10/19/2022
After 8pm on 1/20 experienced low-grade fever, chills, night sweats, and headache. Reports symptoms less severe yhe following morning.
Dears Sirs: At 68 I lead a very sedentary life, working part-time sitting in front of a computer. I do not lift anything heavy than a bag of groceries or participate in any sports. In fact I do nothing that would cause a muscle strain. I had the first dose of the SHINGRIX vaccine on 05/29/18. The side effect that I experienced was pain throughout my deltoid. Even taking NSAIDs the pain was there at rest and pretty bad every time that I had to flex the deltoid, and interfered with my sleep at night. A few days later I saw my GP for another matter, and he said that the pain would go away in a few more days. After two months I was still in pain. I went to my GP and described the pain in my deltoid as a 3-4 at rest, and an 8 whenever I had to use my arm that caused flexing of the deltoid. He put me on a two week regimen of steroids. This greatly diminished the pain, but not totally. After the two week supply of the steroids ran out, the pain came back. His next step was to put me on a stronger steroid. Once again, when the two week supply ran out, the deltoid pain came back. It has now been almost three and one-half months, and the pain in my deltoid is still there, and the second shot is due, which I am not looking forward to it. Both my GP and I believe that this vaccine did some sort of permanent damage to my deltoid muscle. I cannot be on steroids forever. All I want is for the pain to stop. It is greatly interfering with my daily life, and has caused me to use my left arm less and less. This is worrisome because I fear that it will atrophy. This should not be happening. Thank you for your consideration.
This spontaneous report as received from a patient's mother who worked in a physician's office refers to her daughter with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (Lot # not reported) in 2007 and dose 2, 0.5 ml (Lot # not reported) in 2010 and dose 3, 0.5 ml (Lot # not reported) in 2012. There was no concomitant medication. The mother reported that the patient began having irregular periods after her first shot of GARDASIL in 2007, and had a loss of period after her second dose of GARDASIL given to her in 2010. The patient's 3rd dose of GARDASIL was given to her in 2012. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Myalgia & NauseaVomiting Narrative:  Myalgias, body aches on 4/29/21 1 day after vaccine, 4/29/21 1 episode of vomiting.