chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom states pt began trembling while asleep approx 1 hr p/shots given; trembling last for approx 10 sec; mom picked pt up; eyes walled back into head appeared disoriented-drowsy afterwards-slept for 1 1/2 hrs; t102.6 R;
Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Rash at injection site, injection site swelling and tenderness, under arm tenderness, swollen lymph nodes in neck on side vaccine was given.
Pt came in to receive 3rd dose and pharmacist was unaware that the bivalent covid boosters could no longer be given. Pt wanted to receive 3rd dose because they were receiving a bonus if they received another dose in a certain time frame.
Chronic lymphatic leukaemia; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced chronic lymphatic leukaemia on an unspecified date in Apr2021. The patient (caller) stated that she was diagnosed with chronic lymphatic leukaemia, and she did not have a problem in Jan, so it must had happened between Jan and Apr, that particular situation came up. Caller was wondering if the antibodies from the vaccine are compromised when you have chronic lymphatic leukaemia. Caller stated Chronic Lymphatic Leukemia, was one of those that's not really critical, with that type of leukemia you could have no problem for years and years. Caller added, but if the immune system was compromised to a point, would the antibodies from vaccine be destroyed from the chronic lymphatic leukaemia. Caller stated she could find out by being monitored with blood tests and wanted to see had the antibodies changed or not. Caller stated, she had a blood test back in Apr, and that's how they discovered she had chronic lymphatic leukaemia, at her regular doctor's office. She asked them to check for antibodies, and at that time, she did not know if she had chronic lymphatic leukaemia, she asked them to check antibodies since she was vaccinated. Caller stated they said they were good, and doctor would have the numbers, and if she had another blood test to continue checking them, and if the same, then nothing was happening, she could go that route. The patient visited the physician office for the above event. The patient underwent lab tests and procedures which included blood test: chronic lymphatic leukaemia on an unspecified date in Apr2021. Outcome of the event was reported as Unknown.   Information on the lot/batch number has been requested.
cont crying-high, shrill started approx 1/2 hr post immun; lethargic rapid breathing, could not be consoled in any way for 24 hrs; t101-102 range;
He had fever and weakness about three hours after vaccinated on 10/16/00 and never received treatment until 3/24/01 and was not drained in the spine. Abdominal pain, along with constipation. At this time, he has an ileus, and his other complaint is left groin pain, which has be undiagnosed. He kept going into shock up until December. I think his sed rate was still high even though it was in the normal range because his heart was infected, and they didn't send him home with no antibiotics. GBS caused from the vaccines.
Developed covid on 5/6/2022.  Symptoms:  extreme fatigue, chills, body aches, diarrhea, nausea. Treatment:  Paxlovid started 5/7/2022; Cipro started 5/17/2022.
This is a spontaneous report from a contactable consumer (patient). A 52-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# E19263), at the age of 52, via an unspecified route of administration, left arm, on Feb 20, 2021, at 12:45 pm, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient has known allergies to tetracycline. Historical vaccine included the first dose of BNT162B2 for COVID-19 immunisation. The patient did not take any medications in the past two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't tested for COVID-19. On Feb 22, 2021, at 04:00 am, after the second vaccination, patient had fever, chills and body aches that lasted approximately 12 hours. On Feb 22, 2021, evening of the second day after vaccination, she had a red rash  around her neck and on her chest and down her back. The outcome of red rash: unknown, while with other events: recovered (on an unspecified date Feb 2021). Follow-up (May 14, 2021): Follow-up attempts completed. No further information expected.
Patient presented to Emergency Department on 4/10/21 with moderate SOB experienced in the middle of the night. She experienced SOB when she woke up in the middle of the night on 4/9/21 that made it difficult for her to walk back to her bed from the bathroom. Oxygen reached as low as 80% while in the hospital and she was discharged with oxygen for use at home. She received her first dose of Moderna COVID vaccine on 4/9/21. She was last hospitalized from 1/26/21 to 2/5/21 for tachybradycardia syndrome for which a pacemaker was placed. She also developed COVID19 infection while in the hospital at this time and was discharged with oxygen that was a returned back to supplier after 1 week.
Pt called on 8/4/00, questioned if TD could be causing her neck pain and breast pain on the same side as the injection. The RN suggested she call her doctor if it doesn't go away. On 8/9/00, client called by nurse and she said she had difficulty raising arm also but now has only soreness at injection site with small knot. She had not contacted her MD but will discuss it with him.
Woke up at 11/132021 4:30AM with fever (101.4), injection site pain and chills. Took Tylenol. Later in morning experience nausea and vomiting for "a couple hours".  Fatigued throughout day. Reports feeling better 1/14/2021.  Spoke to Dr (PCP) he has recommended getting 2nd dose when she is able
Patient received Kinrix vaccine in left arm on 08/14/19. He developed localized redness on 08/16/19, this improved, then on 08/18/19 he developed an extensive rash on left upper arm over deltoid, medial aspect of both knees and thighs, and was beginning to develop the rash on his torso with small red spots. Patient did not have any noted fever, and denied any discomfort at the sites. Parents reported no behavioral changes, no lethargy, no loss of appetite or other concerns beyond the rash.
Based on provided records, patient was due for Moderna #2 which was administered at appointment on 3/16/2023. After vaccination, I had requested the COVID card given to them at last appointment at Health Department on 02/14/2023 with Moderna #1 to document Moderna #2. Patient handed me COVID card with Pfizer #1 FP4554 administered on 07/10/2022 at facility. Patient was monitored after vaccination, with no adverse effects observed.
Onset headaches, eye floaters, light sensitivity, fatigue/malaise, elevated blood glucose levels
Body aches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced MYALGIA (Body aches) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Body aches) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-132957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information include no new information.
About a week after my second dose I had severe muscle pains (legs, hips, back, and jaw) and trouble breathing. I went to my doctor and was tested for the flu and covid19 and various other things and everything came back negative. I was given prednisone and about a week later the symptoms went away.
Focal seizure  2 hours after vaccine given... partial seizure 24 hours after give
BLISTER ON OPPOSITE ARM OF INJECTION WITH PURPLE POOLING BLOOD UNDERNEATH/WIDE AREA OF NEEDLE STICK LOOKING DOTS OF BLOOD; BRUISING ON OPPOSITE ARM OF INJECTION; RASH ON OPPOSITE ARM OF INJECTION; BLURRING OF VISION; This spontaneous report received from a patient 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurring of vision. On 09-APR-2021, the subject experienced rash on opposite arm of injection. On 09-APR-2021, the subject experienced blister on opposite arm of injection with purple pooling blood underneath/wide area of needle stick looking dots of blood. On 09-APR-2021, the subject experienced bruising on opposite arm of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurring of vision, rash on opposite arm of injection, blister on opposite arm of injection with purple pooling blood underneath/wide area of needle stick looking dots of blood, and bruising on opposite arm of injection. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
tested positive for covid on 7/21/2021 Completed the covid vaccine series. Moderna 1/27/2021, 2/24/2021
AFTER TWO WEEKS OF THE SECOND DOSE IN MARCH 12, 2021 RASH STARTED AT THE ARMS AND NECK AND UNDER THE BUST.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an expired dose of with M-M-R II 0.5 mL vial, subcutaneously, with lot # M045101 and expiration date on 10-NOV-2018 for prophylaxis. The vaccines was diluted on sterile diluent. No adverse reactions were experienced by the patient.
Red raised welp at injection site.  Larger than a quarter but small than a half dollar. Painful to touch but I'm not going to my doctor because of it.  Unless it gets a lot worse later.
Area is extremely hot to the touch, Hives below the site, bruising, pain with movement at shoulder.
Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, chills, axillary lymph node tenderness and swelling, fever (Tmax 102.2).  EE reports she called off of work Monday but later came to work later at approximately 09:00.  EE reports Monday resolution of all symptoms except still worsening lymph node tenderness and swelling.  EE reports she emailed Woodlands EH RN and advised to contact HR vaccine support line to notify of adverse reaction.  EE report she filled out V-safe.  Last day of work and shift - ?currently working today Home remedies? -   rest and motrin (last dose at 8:30 PM on Sunday 1/10) Any improvement? ? EE reports resolution of all symptoms except lymph node swelling and tenderness Recommendation?  EE encouraged to rotate Tylenol and motrin q3h and to contact PCP for appointment.
20APR98 PMD visit;22APR98 ER, blood test (inflammation) in joints) ibuprofen;since then SOB, tired, arthralgia (constant);
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
no other AE; administered a dose ofROTATEQ to a 7 month old patient that was expired on 3/19/2021; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender. The patient concurrent condition, medical history and concomitant medication were not provided.   On 22-MAR-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660693, expiration date 19-MAR-2021, 1 dose, administered orally (strength was not provided) for prophylaxis. The vaccine did not experience any temperature excursions prior to administration. No other adverse event was reported. The nurse wanted to know if there was any recommendation on whether or not the patient should be revaccinated. The outcome was unknown.
Information has been received from a physician concerning a male patient between the age of 5 and 11 years old who was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. Subsequently, the patient developed breakthrough varicella. The case was mild with few lesions. The lesions started out maculopapular and slowly became vesicular. Unspecified medical attention was sought, but prescription drug treatment was not required and laboratory tests were not performed. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. The reporter also mentioned three other patients who each developed breakthrough varicella post vaccination with varicella virus vaccine live. Additional information has been requested.
pt recv vax & became very stiff, shoulder rolled forward, mom stood child up eyes were open, no change in skincolor, child cont to breath;p/15sec child unresponsive, eye still open began to gasp air & began to cry;
pt recvd vax by the same day that evening lt elbow began bothering  progressively getting worse afeb;no abn @ inj site; lt elbow stiff, ROM is limited;lt wrist is swollen & stiff;ROM is limited;elbow is no warmer than rt;
Information has been received from a physician concerning an approximately 45 year old male with a hx of catarax surgery after an eye injury (in approx 1985) who on 13MAR2004 was vaccinated with a dose of MMR. On 13MAR2004, the pt was concomitantly vaccinated with a dose of tetanus toxoid. On 19MAR2004, the pt contacted the physician and reported he was experiencing sexual dysfunction with ejaculation and erection problems. Unspecified medical attention was sought. Additional information has been requested.
I suffered a Transient Cerebral Ischemic Attack. I never had an issue like this before. My husband couldn't wake me in the morning so it happened sometime in the night. I ended up not knowing anything until 9pm that evening.
Patient given Pfizer Pediatric Covid-19 vaccine WITHOUT DILUTION. No adverse effects observed in-store. Messages left for primary care physician and mother of child to contact the pharmacy. Pfizer Medical Information contacted and error reported to Drug Safety department. At this time, Pfizer had no specific steps to take other than supportive care for any local/systemic effects that may occur. They did not recommend repeating the dose, and the second dose may be administered at the normal interval of 21 days later. Any judgment to NOT give the second dose must be evaluated on a case-by-case basis.
pt recv vax 26JAn99 & 9FEB99 started w/temp of 101, Tuesday & Wednesday; 11FEB pox began on stomach, hands, fingers, back & diaper area;about 30 pox;child cranky & uncomfortable MD dx;
We  inadvertently administered the vaccine past the 30-day Use by Date. According to the manufacturer the vaccine administered on June 8 and 9, 2022 from lot number 065K21A likely did not  maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Fever started at 6pm and continued to increase until reaching 103 degrees. I had muscle aches, headache, and joint pain and spasms. Fever broke by 9am. Body aches, headache, and tiredness continued throughout  the day.
On February 8th, 2021, I developed a severe case of shingles on my right chest and back.  I visited my physician on February 11th  and he prescribed an after-the-fact  antiviral drug (10 day course of treatment).  Today, May 22, 2021, I am still experiencing residual pain from the shingles.  In addition, I have developed irritation of my stomach which has not yet been diagnosed.  It is my belief that this stomach problem is directly related to the shingles outbreak:  two days before I noticed the shingles sores, I experienced a severe stomach upset w/belching, as well as flashes of fever; this lasted approximately two or three hours.
Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: 911 was called when pt reported trouble breathing. EMT came. Her oxygen level was low. Oxygen was given and her O2 went up to 95 after oxygen. They then took her out to the ambulance to check up on the patient
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 60 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: after completing Paxlovid and testing  negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 27Sep2023 to 01Oct2023.
Dizziness, weakness, blurred vision/ spots, diaphoresis, feeling hot, tingling in toes, lethargy. Resolved in < 45 minutes.
Information has been received from a Medical Assistant coworker concerning a 60 year old female with a drug reaction to PERCOCET, that produce to her nausea and vomiting with no medical history reported, who on 05-FEB-2009 was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (Merck) (lot number: 663195/1416X). Concomitant therapy included PROZAC and trazodone HCl. The Medical Assistant reported the patient experienced tingling, numbness and burning 24-48 hours after the vaccination (approximately on 06-FEB-2009- 07-FEB-2009). An unspecified Neurologist confirmed the Post herpetic neuralgia diagnosis when the patient's symptoms first occurred after vaccination and confirmed the patient did not have shingles or any symptoms of shingles. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by a recent visit to the physician's office. Follow up information has been received from Medical Assistant concerning a female patient with allergies to oxycodone (manufacturer unknown) and no illness at the time of vaccination, who was vaccinated with a dose of ZOSTAVAX on 05-FEB-2009. The Medical Assistant reported that on 12-FEB-2009, the patient developed burning pain in the right arm numbness, tingling in all extremities, tremor in both hands, fatigue and weakness. On an unspecified date the patient sought a neurologist and confirmed a post-herpetic neuralgia. The outcome of the patient was not recovered. Post-herpetic neuralgia was considered to be an other important medical for the reporter. Additional information has been requested.
7 hours after first COVID-19 dose he experienced dysosmia x 1 hour which spontaneously resolved (not a/w dyspnea, cough, fever, lost of taste, nausea, or vomiting).  He did not seek medical attention.
Fever 101,  Muscle and Joint aching, tired.  Lymph node swollen in left armpit
a 75 year old patient is in a clinical trial and received BEXSERO; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 74-year-old female patient who received Men B NVS (Bexsero) (batch number m7455, expiry date 31-DEC-2022) for prophylaxis.   Concomitant products included MENQUADFI.   On 30-NOV-2022, the patient received the 1st dose of Bexsero. On 30-NOV-2022, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a 75 year old patient is in a clinical trial and received BEXSERO). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-MAY-2023 The registered pharmacist called to inform  that the elderly patient was in clinical trial and received Bexsero.  The patient also received Menquadfi last fall. The reporter also stated she believed that through the clinical trial patient could be receiving a complement inhibitor. The patient had not yet received the second dose of Bexsero. The reporter consented to follow-up. The patient received Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.