chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia 120-135 BP90/47 Fever,chills,  fatigue  Temp 101.6 Light headed Severe headache COVID Fog Injection given 11/18/21 at 530 pm All s/s started 11-19-21 at 1000am. S/S lessened on 11/21/21 and gone except tachycardia on 11/22/21.
Syringomyelia/ Syringobulbia; Suicide attempt; Memory loss; Blood clot; Depression; Osteoarthritis of spine; Weight loss; Ended up getting 5 anthrax shots within a few months; Fainting; Little muscle pains; Aches/ pains; Information received on 25/JUN/2019 from: a consumer.   A 43-year-old male consumer (weight: 197 lbs/ 89 kg and height: 6'1" inch) experienced Syringomyelia/ Syringobulbia, Inappropriate schedule of vaccine administered, memory loss, suicide attempt, blood clot, aches/pains, little muscle pains, fainting, depression, osteoarthritis of spine, and weight loss, following the administration of BioThrax intramuscularly.  In Dec 1998 and Jan 1999, the consumer received 2 shots of anthrax vaccine, but these were not put in his medical records. After his return in Feb 1999, the vaccine was restarted. He received three shots at 0, 2, and 4 weeks, respectively. He received total 5 shots and the last one was administered in Apr 1999. Later, he had a PPD (purified protein derivative) reaction after the administration of third anthrax shot. He had a chest X-ray which was negative for tuberculosis. He received a 6 months' treatment with Isoniazid (INH) as a precautionary measure and had chest x-ray every year. The patient also attempted suicide on 07-Dec-2010. His memory from the event was not very good as he suffered memory loss. Following his suicide attempt, blood clots were identified which were there even before and for which he was given a blood thinner as treatment. He also took Naproxen for pain at that time. The patient was admitted to mental home for days or weeks. The consumer also experienced pain, little muscle pains, memory loss, fainting, and depression. He took Zoloft in addition to tramadol and marijuana for pain. He was diagnosed with osteoarthritis of the spine at the age of 32 or 33. Later the patient had a Magnetic resonance imaging (MRI) which found a cyst on his spine. The patient was diagnosed with syringomyelia and syringobulbia. These conditions were affecting him from his head to his butt bone. Recently, he had also been experiencing weight loss (about 30-40 lbs). Outcome of the events were unknown.  Treatments included: Blood thinner for blood clot, naproxen for pain, Zoloft in addition to tramadol and marijuana for pain.  Relevant laboratory / Diagnostics: He had a chest X-ray, scan, and MRI. Chest X-ray: tuberculosis-negative. MRI: cyst on his spine   The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.; Sender's Comments: The Company considers the events to be not related to the BioThrax injection. Based on the case scenario a causal relationship between the intake of vaccine and events cannot be established. There is no medically plausible explanation for occurrence of events in association with the vaccine.
Not feeling good; Positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for covid-19) and FEELING ABNORMAL (Not feeling good) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for covid-19). On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling good). At the time of the report, COVID-19 (Positive for covid-19) and FEELING ABNORMAL (Not feeling good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068650:husband case
SUSPECTED CLINICAL VACCINATION FAILURE; GOT (COVID-19); This spontaneous report received from a patient via social media via company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, was administered on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the patient got CV (covid-19), and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got CV (covid-19) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187876.; Sender's Comments: V0: 20210800676-Covid-19 vaccine ad26.cov2.s -Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt recvd vax & 2 wks following vax pts irritable bowel disease exacerbated;
Friday had shingles shot in L arm flu & pneumonia in R. I "think" my bad reaction was with pneumonia. When received shot pharmacist said my skin at injection site moved with little bumps. He'd never seen it before. Later pain made it difficult to sleep. (Expected) Took ibuprofen. Next day arm from elbow up was very red, swollen where I couldn't bend my arm. Very painful. I called to let pharmacy know. Fever up to 101. I took ibuprofen all day. Sunday eve was going to go to walk-in but they were closed. Talked with ER and considered going. Took photo of my arm. Monday fever was gone. Redness less. Stopped by Dr's Office so they would know about it. Saw staff. Called pharmacy again to update them. Tuesday arm better but needed to use my inhaler two times. Very very rarely need to use. Coughed a lot. Wednesday (today) breathing better but not normal. Some chest congestion. Throat scratchy, general malaise. Arm almost back to normal. Contacted pharmacy again and they suggested I contact you. I feel now I should have gone to see someone right away.
having chills; feeling warm; sore in her arms; Moderna as the 2nd vaccine after having Pfizer as the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine). At the time of the report, CHILLS (having chills), FEELING HOT (feeling warm), MYALGIA (sore in her arms) and OFF LABEL USE (Moderna as the 2nd vaccine after having Pfizer as the first vaccine) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1/22/21 AM BODY TEMPERATURE WAS 102.3(F). RAPID COVID TEST RESULTS: NEGATIVE. 1/25/21 AM BODY TERMPERATURE WAS 104(F), ALSO RECENT SERUM LAB TEST DEMONSTRATED ELEVATED LIVER ENZYMES
Lower extremity weakness, was admitted to medical center, found to have Guillain Barre Syndrome, given IVIG and plasmapharesis without improvement and now worsening.
RN accidentally administered 1mL of IPOL in error instead of 0.5mL with no adverse event; Initial information received on 08-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 19 years old male patient who experienced rn accidentally administered 1ml of ipol in error instead of 0.5ml with no adverse event after receiving vaccine IPV (VERO) (IPOL).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) for Prophylactic vaccination; TYPHOID VACCINE POLYSACCH VI (Typhim VI) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 08-Apr-2022, the patient received a dose of suspect IPV (VERO) at a dose of 1 ml with lot U1C571M via subcutaneous route in right arm for Immunization (incorrect dose administered) (latency: same day).  Reportedly she is asking if there is anything that they should do. She verifies that there are no adverse effects observed at the time.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (RN accidentally administered 1mL of IPOL in error instead of 0.5mL with no adverse event).  At time of reporting, the outcome was Unknown for the event rn accidentally administered 1ml of ipol in error instead of 0.5ml with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Client stated she felt dizzy briefly after the vaccine .  she recovered quickly to base line and was released.  Advised to seek medical attention later if needed.
FATIGUE; This spontaneous report received from a patient via a company representative 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
suffered significant undisclosed side effects that have affected his social life and his marital status; suffered significant undisclosed side effects that have affected his social life and his marital status; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOCIAL PROBLEM (non-serious), MARITAL PROBLEM (non-serious), outcome "unknown" and all described as "suffered significant undisclosed side effects that have affected his social life and his marital status".  Additional information included: The report was not related to a study or programme. On 25Jan2022, the Pfizer employee received the voicemail at 13:32 PM and he listened to it at 15:30 PM. Pfizer employee stated that he received a voicemail from someone calling to say, he assumes for Pfizer, that they are having side effects from Comirnaty. There was very little detail in the voicemail and he guessed that the little bit that he does know he had to report. The patient was suffered from adverse events from Comirnaty and that's all that the Pfizer employee knows. The person who left the voicemail stated that he has "suffered significant undisclosed side effects that have affected his social life and his marital status that was the only level of detail.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt a little tired the next day after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Felt a little tired the next day after receiving the vaccine) in a 47-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (All previous doses for them were the Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer.  On 03-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 04-Sep-2022, the patient experienced FATIGUE (Felt a little tired the next day after receiving the vaccine). At the time of the report, FATIGUE (Felt a little tired the next day after receiving the vaccine) had resolved.     Concomitant product use was not provided by the reporter.  It was reported that patient felt a little tired the next day after receiving the vaccine but felt fine after.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-640773, US-MODERNATX, INC.-MOD-2022-640772 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-640773:Husband case US-MODERNATX, INC.-MOD-2022-640772:same reporter as  ( Case for husband and wife )
Chills; high fevers 103.5; achy joints; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 14Mar2021 at 08:00 hours as dose 2, single (at the age of 54-years) for COVID-19 immunisation. Medical history included Acquired Immunodeficiency Syndrome (AIDS), Non-cirrhotic hyper portal tension, low platelets and known allergies: penicillin (all from an unknown date and unknown if ongoing). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6198 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 at 08:15 hours as dose 1, single (at the age of 54-years) for COVID-19 immunisation. Concomitant medication(s) included cobicistat, darunavir ethanolate (Prezcobix) taken for an unspecified indication from an unspecified start date to 14Mar2021; nadolol (Nadol), valacyclovir, levothyroxine and PRA (all taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. On 14Mar2021 11:00, patient experienced chills, high fevers 103.5, achy joints, headache, the patient has not been tested. On an unspecified date the patient underwent lab tests and procedures which included body temperature result was high fevers 103.5.  Therapeutic measures were taken as a result of all events. The outcome of the events was not resolved.   No Follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# J006245, expiry date: 03-FEB-2016 and lot# K008334, expiry date: 09-JUN-2016), dose, route, frequency unspecified (Incorrect storage of drug). Other suspect and concomitant therapies were not reported. No adverse symptoms reported. No product quality complaint (PQC) involved. Additional information has been requested.
12/19 vaccination 12/24 fever, malaise, body aches. Lasted for 5 days.
pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left side of the head and ear. The left side of his was face numb and he lost all hearing in left ear.  He went to ER on 4/22/21.  They removed ear wax and was prescribed amoxicillin and Mucinex.  His symptoms did not improve so went to his PCP, on 4/29/21( he had to see his assistant ). They prescribed prednisone 40mg.  He was referred to ENT.  He saw her on 5/3/21.  He was then prescribed 60mg prednisone and was given a hearing test.  He had lost 20% of hearing at that point.  He went back to ENT on 5/10/21 and had another hearing test.  His hearing was better and almost back to normal but says he continues to have ringing in his head.  He has a MRI scheduled on 5/24/21 further treatment.
Colleague states she felt whole body fatigue and achiness for 3 days following the injection.  States left upper arm was extremely sore that entire time as well.
Diffuse and generalized hives Swelling and hard knot to injection site  Low temp of 96.5 with chills  Bloody sputum from mouth and nares  Headache
Patient received yellow fever vaccine on 1/09/2012 on his (L) thigh. Traveled on 01/13/2012, returned on 01/20/12 after visiting (summer hot, humid, mosquitoes). Mom noticed a bump (01/16/12), mobile, non-tender, 5x12 mm node and 5x13 mm node in the (L) groin.
Itching around the vaccination site began in the evening 8 days after the vaccination (4/13/2021).  I woke up to a red spot around the vaccination site the morning of 4/14/2021.  There is no pain, swelling or fever.
The pt experienced swelling, pain, warmth to the left deltoid muscle and mild left neck pain, 2 days post vax. Treated with Allegra, Naprosyn, and Ice
On 2/5/21- Patient reported getting her 1st moderna COVID vaccine.  1 hour after the vaccine she developed "tingling throughout" her body.  3 hours later developed fever, nausea, dizziness, tachycardia.    On 2/6/21- She woke up reporting facial swelling and swelling to her eyes and lips.  C/o chest tightness, soreness, and rash on her chest and shoulders.   Her symptoms resolved during the day on its own without any intervention.   Pt. did not need to seek care at the hospital or with a provider.  Reaction was self-reported on 2/10/21.
No additional AEs; expired dose of MMR II administered; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated with the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (rHA))(M-M-R II) subcutaneous injection, 0.5 milliliter, subcutaneously for prophylaxis (lot # was T018669, expiration date was reported as 29-MAY-2022; strength was not provided) (expired product administered). No additional adverse events were reported (no adverse event).
Per mom, had intermittent headaches and dizziness for several months. Had a possible seizure, syncope of 9-22-08. Called 911 tonight by ambulance to local hospital. Saw Neurologist 9/23, 24.  10/14/08 Reviewed ER medical records of 9/23/2008. FINAL DX: vasovagal syncope, possible seizure Records reveal patient experienced fall in bedroom after standing from bent over position w/mild shaking, mild abdominal pain.  Tx w/IVF & d/c to home.
I received the first series of Pfizer vaccines in December then in January. In April I began to have gum irritation and sores. I went to my dentist who was perplexed, tried nystatin oral mouth wash then CHG mouthwash, elimination of certain mouthwashes/toothpaste/ changed my tooth brush etc. Then in the end of July, the oral sores continued  I began to have blistering skin lesions, under my right breast on my upper abdomen. In the beginning of September of 2021 I received my Pfizer booster and my job, following that my right breast blister became significantly worse, lesions popped up on my right upper back/right lower back/right lateral neck and my oral lesions became more painful to the point I wasn?t able to eat anything hard. I went to the dermatologist immediately following, I was arrested with doxycycline/ketoconazole cream- no change. Then he performed a biopsy/prescribed my hydrocortisone cream. The biopsy came up consistent with pemphigus vulgaris - I was started on prednisone 10 mg daily and betamethasone ointment for my skin, I then completed blood antibodies testing (came back negative). I then started seeing Dr. a oral pemphigus expert who biopsied my mouth which also came up positive for pemphigus vulgaris - I was started on oral swish and split clobatasol in February of 2022 - which I am not slowly titrations off of. I saw  pemphigus expert Dr. in December of 2021, by that time my lesions were ?healing? on there own without steroid treatment, saw him again in March of 2022 where my lesions were gone, just left with scars - perplexing him since that doesn?t happen with pemphigus.
Red spots, arms, legs, trunk area. Itching. Rcv'd inject at ER.  Rash for 2 days. Resolved.
Pt was given first dose of Moderna before realizing  that pt had been given first dose of Pfizer on 8/11/21.   Pt was scheduled to return to clinic for second dose of Moderna on 9/28/21.
After getting my COVID-19 shot I was having fever symptoms and chills and then would be burning up. I was nauseated and had no appetite. About a week later I was feeling like I could not catch my breath no matter what I did and then I was having horrible headaches as well. Nothing would take that headache away either. I was not able to really do anything. I was supposed to be hosting family gatherings and I was just exhausted, I took a COVID-19 but they were never positive. I did have some low-grade temperatures and I was just unwell. I then started being unable to take a deep breath and it was like I could not fill my lungs up with air. I was also getting out of breath with anything that I did. I saw my PCP and an ENT and this led to nothing helpful. I then went back to my PCP and I was put on an inhaler and that seemed to help I saw a huge difference with my symptoms and started feeling a little better. I am still not back to normal but the inhaler seems to help.
For 5 months I have experienced pain in my left hip, left knee and left spine. I take controlled substance for arthritis the pain has been at an incredible flare. I have been to lots of doctors Orthopedic for knees and hips, Spine Orthopedic for back and referred to physical therapy. I have had 22 sessions of physical therapy. I'm experiencing having a hard time sleeping. I developed pneumonia for 2 weeks given antibiotics, not sure if any of this is related this is only thing changed getting the vaccine.