chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the first one I had felt some pain in the area and some spasm in my neck; In the first one I had felt some pain in the area and some spasm in my neck; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril. The patient reported that in the first one (first dose), she felt some pain in the area and some spasm in her neck. The outcome of the events was unknown.
PT WAS ADMINSTERED 0.5 ML INSTEAD OF 0.25ML FOR 4TH BOOSTER DOSE
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
Left deltoid hive itchy length 5 inches. No SOB, fever or signs of infection. Pt. advised to take BENADRYL ice area. Pt. only iced area and was fine next day.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided, For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication reported.  On 27-Sep-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Pain; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003594.  A female patient received BNT162b2 (BNT162B2), on 02Oct2021 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
+4? large welted, hot, itchy, swollen  area at injection site, fever, body aches, nausea, vomiting, severe headache, dizziness still present as of today 1/14/2020.
The patient was due for the 2nd dose of SHINGRIX and wondered if the 2nd dose of SHINGRIX could be administered. This case was reported by a other health professional via sales rep and described the occurrence of tinnitus in a 51-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced tinnitus and partial hearing loss. On an unknown date, the outcome of the tinnitus and partial hearing loss were unknown. It was unknown if the reporter considered the tinnitus and partial hearing loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 51 year old at the time of reporting. The patient experienced tapping in ear several days after receiving SHINGRIX. Followed up to check the symptom with ent doctor, it was indicated that the patient had some partial hearing loss in ear. The reporter was not sure tapping in ear or hearing loss has any correlation to administration of SHINGRIX. The patient was due for the 2nd dose of SHINGRIX and wondered if the 2nd dose of SHINGRIX could be administered.
Patient felt fatigue after 2nd dose. Collapsed few days after booster. Diagnosed with endocarditis which was resistant to all antibiotics tried. Patient died 1/10/22. Death certificate says Aortic Valve Endocarditis caused by Unclear Etiology.
The evening after vaccine the patient had chills and was shaking. Was better the next day. But 2 days later experienced shortness of breath and chest tightness. He went to the hospital and was admitted.
swollen axillary lymph nodes on the same side vaccine was given.  Prescribed Ibuprofen 600 mg tablet by primary physician
21APR98 fever 99.4 to 99.8;22APR98 2mm red, raised bumps all over body no itching;
3 days after Td shot, arm felt heavier, sharp pain "like a knife stuck in my bones." Called nurse to take Tylenol call back if sx continue. Called back 1 wk later-states pain in arm wsa worse, encouraged to see MD. Nurse at MD's office to take Tylenol scheduled appt. in 1wk. Pt did not keep appt because the pain went away. In office today, states no pain/no pain arm movement. No swelling or redness or knot noticed at site.
Flat, red rash across chest.  Not itchy or painful.  Low fever, myalgia, headache, fatigue also experienced the day after vaccination.
Pt. felt faint, BP taken 60/40, pt. given water, pt. had not eaten since late am, pt. given granola bar, re: check pt. BP after eating & drinking water 80/60. Pt. reported feeling better after resting and eating/drinking.
ON 01/01/18 (2 WEEKS AFTER IMMUNIZATIONS WERE PROVIDED) AROUND 1900 PARENT NOTICED LEFT ARM HAVING MORE REDNESS AND BLISTERS AROUND INJECTION SITE OF WHERE THE VARICELLA VACCINE WAS GIVEN. DENIES ANY FEVER OR REDNESS PRIOR TO THIS DATE. ON 01/03/18 CHILD WAS TAKEN TO PCP AND PROVIDED A TOPICAL CREAM TO APPLY TO SITE. PCP'S NURSE CALLED ON 1/3/18 TO REPORT THE ADVERSE REACTION. MOM BRINGS CHILD IN TODAY AND NO REDNESS NOTED. SITE STILL HAS CIRCLE OF CRUSTED SPOTS AT INJECTION SITE. MOM VERBALIZES UNDERSTANDING THIS IS NORMAL REACTION AND WILL PLAN TO CONTINUE TO VACCINATE CHILD AS NEEDED.
Diarrhea for almost a week after.    Short of breath, elevated heart rate with no physical exercises and random times.  Fatigue.    First month after the second shot was really bad, it has been getting better slowly.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. Concomitant medication(s) included: CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; CENTRUM A TO ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (Sep2022) Positive, notes: tested positive after taking Paxlovid. Therapeutic measure, Paxlovid from 08Sep2022 to 12Sep2022, was taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
on 5/28/2021 I went to the emergency room after experiencing chest and jaw pain that radiated down the back of my arms. I was diagnosed with a heart attack and admitted for a cardiac cath. I did not receive a stent as they did not initially find any blockages however, upon further review a small blockage was found but it did not require a stent.   After follow up I was diagnosed with a myocardial infarction, coronary artery disease with angina. After the cardiac MRI  I was diagnosed with myopercarditis as well.
Joint pain, nausea, abdominal pain, headache, blurred vision, rash to thighs, malaise, chills, extreme agitation. Treated with Toradol 60mg IM, Toradol 10mg  PO Q 4-6 hours PRN, Ativan 0.5mg PO BID PRN, Vistaril 25mg Q 4-6 hours PRN.
Information has been received from a physician concerning a 4 year old female, with no pertinent medical history, drug reactions or allergies who on 25-APR-2008 was vaccinated subcutaneously with 0.5 ml of MMRII (lot #657249/0526U).  Concomitant vaccine therapy included tetanus toxoid (MFR unknown), poliovirus vaccine (MFR unknown) and PREVNAR.  On 04-MAY-2008 the patient developed pain at the site of a swollen parotid gland.  The patient was treated with an anti inflammatory medication and fluids.  There was no product quality complaint.  At the time of reporting the patient was recovering.  Additional information has been requested.
I urinated 5 times last night, which is more often than usual; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, 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: POLLAKIURIA (non-serious), outcome "unknown", described as "I urinated 5 times last night, which is more often than usual". Additional information: The consumer also stated: "I also received the same Pfizer Covid 19 vaccine at the same time with my wife and I have no side effects whatsoever.  No discomfort of any kind.  I don't know if it did anything to me, but I urinated 5 times last night, which is more often than usual. I am not concerned about it.  Male patient; Age=87 years old."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vaccine at 1245pm on 12/16/2020,  severe migraine 12/16/2020 at 6pm vomiting 8pm 12/16/2020 both continued all night and the next day 12/17/2020 I couldn?t eat or drink I would vomit it back up even water, went to Urgent care at 11:30am 12/17/2020 where they covid tested me with a Rapid swab and a PCR swab, gave me zofran for the nausea and a shot of Troradol for the migraine, called me in a prescription for Zofran and Ibprophen 800mg. Couldn?t work that night due to still feeling ill tired and weak, and dealing with the headache. 12/18/2020 no more vomiting or headache just feeling extremely tired and drained, slept most of the day and started having stomach cramps became constipated  so I had to take Miralax and use a suppository and stool softener, 12/19/2020 finally went to the restroom and after that had diarrhea for the rest of the day. All symptoms subsided by 12/21/2020.
Swollen/redness of the Uvula in throat. Started 6am 3/10/21 and still going as of now 3/11/21 at 10pm.
Patient states that on 01/15/2021 she begin to experience itching, redness and hard knot on arm she received vaccine in. Patient states that redness seems to be more prominent today than what she notice before.  She also reports feeling fatigue which she is still experiencing.  She reports having chills which started on 01/15/2021 and ended yesterday. Patient also states that she did experience one bout of nausea and one bout of diarrhea on 01/15/2021. Patient is under the care of a physician. Advised patient to call her physician to seek medical advise. Patient states that she will present to clinic for evaluation.
upper back pain/ my upper back is really hurting me bad; She stated she is in pain and could not continue the phone call. 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 52-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Third dose (1st booster), MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "upper back pain/ my upper back is really hurting me bad"; PAIN (non-serious), outcome "unknown", described as "She stated she is in pain and could not continue the phone call."  Additional Information: Consumer stated, "I am just wondering, I had the COVID booster shot, my 2nd booster and my upper back is really hurting me bad. Is that a common side effect from that or uncommon side effect?" Consumer was provided Pfizer Medical Information department. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain & swelling lt thigh w/some reddness above lt knee laterally; pt cannot bend lt knee & walk because of pain;
On the inner side of her thigh, what the hell is that on my leg; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (On the inner side of her thigh, what the hell is that on my leg) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNEVALUABLE EVENT (On the inner side of her thigh, what the hell is that on my leg). At the time of the report, UNEVALUABLE EVENT (On the inner side of her thigh, what the hell is that on my leg) outcome was unknown.
States she received flu vaccine 2/4/14 and had pain in right arm during week. States pain started moving to right shoulder on 2//9/2014 - states when she moves right arm it hurts. Denies arm being puffy/swollen.
Chills; fever of a 102; I threw up; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included COVID. The patient's concomitant medications were none. After vaccination, the patient had terrible side effects, she thought she had COVID again. She had chills, fever of a 102 and she threw up that lasted a day. Her test was on the 17Jan2021 (also reported as 17Nov2021). Will that be anything that interfere with the shot? The patient received paracetamol (TYLENOL) for treatment. The outcome of event 'threw up' was recovered in Jan2021; of rest events was unknown.
Fatigue, headache, chills, nausea, vomiting, dizziness and weakness
Numbness in leg and arms, increase in back pain both in level and duration. Minor Light headedness or numbness in brain.
A few weeks receiving the Jansen vaccination, I started having chest pressure and pain.  On June 2, 2021, I had severe pressure and pain in my chest.  I went to the ER.  An EKG indicated an abnormal heart problem.  An angiogram revealed an artery blockage.  A stent was inserted into the artery to resume blood flow.
Facility reported patient needed 1st dose and scheduled with Mobile Team 4/15/2021. Mobile Team vaccinated on 4/15/2021 patient with Pfizer. However when scheduling the 2nd dose clinic in a different system than the first appointment, the records showed that the patient received 1st dose 1/29/2021 Pfizer and 2nd dose 2/19/2021 Pfizer. Conservator and facilty reported no injury or issues post vaccination.
This spontaneous report as received from a medical assistant refers to a 10 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Initial report received on 11 March 2008 from a health care professional. A 31-year-old female patient, with a history of mitral valve prolapse, had received a second dose, left arm, intramuscular injection of JE-VAX, lot number EJN233B, and a second dose, left deltoid, intramuscular injection of Imovax, lot number A0209-2, both administered on 06 February 2008; and a fourth dose, oral administration of Vivotif, lot number 3001291, on 07 February 2008. The patient also received a left deltoid, intramuscular injection of Adacel, lot number C2864AA.; a left arm, intramuscular injection of IPOL, lot number A0170-2; a left arm, intramuscular injection of MMR vaccine, lot number 1312U; a right deltoid, intramuscular injection of Fluarix, lot number AFLUA303AA; and a right deltoid, intramuscular injection of Twinrix, lot number AHABBLOOA; on 30 January 2008. The patient's last menstrual period was 20 January 2008. Twenty-two days following the 06 February 2008 immunizations (and 29 days following the 30 January 2008 immunizations), the patient developed abdominal cramping and bleeding with "large pieces of tissue." She was examined by an obstetrician and diagnosed with a miscarriage. Relevant diagnostic testing was reported as none. Concomitant medications included vitamins and aspirin. The patient subsequently recovered from the event.
I was vaccinated on 2/13/21 at 9:30 AM. Within 12 hours, I started having symptoms. It started with a headache, possibly a fever, chills. I felt extremely tired and I was in a fog for a couple of days. After that, I had stomach ache and diarrhea. I threw up once and had diarrhea a couple of times. I had a rash on both arms and my chest, my neck, and half of my face. As of now, my left armpit still aches frequently (almost constantly). I now have constant postnasal drip, and I never had that before the vaccine. After my vaccine, my symptoms lasted 7-8 days, though I still have the postnasal drip and achy armpit.
The pt came in and her arm was red with a rash and she said it was extremely hot and real sore. I counseled her and told her to put some ice on it and take some TYLENOL and BENADRYL and asked her to sit and wait til the manager come back from lunch to talk with her, she said she was in a hurry and just wanted us to see it. I told her the manager would call her and advise her further and I gave it to the manager. The pt may be having a reaction also because she had the same shot PREVNAR 13 on 3/21/2018. I will call the pt again to check on her but she told the pharmacy manager she would come back in on Friday or Saturday.
REALLY BAD SIDE EFFECT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) once a total dose was not reported, administered on 07-MAR-2021 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 2021, the subject experienced really bad side effect nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really bad side effect nos was not reported. This report was non-serious.
Chills 1:20 am Very stiff right arm 1:20 am Lethargy for 6 days Mild diarrhea days 1 and 2 Urine more frequently than usual
Shingles/ shingles lasted several months causing severe pain and suffering which; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about June 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (dose, administration route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles.  On or about August 2016, the patient was diagnosed with shingles by the attending physicians at the hospital. Patient's shingles lasted several months causing severe pain and suffering which required multiple trips to the Emergency Department. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. The patient sustained severe and permanent personal injuries.  The outcome of the shingles was unknown and the causality assessment between this and the vaccination with zoster vaccine live (ZOSTAVAX) was considered to be related. Upon internal review, the singles was consider as serious due to disability.
Was diagnosed with covid; Was diagnosed with covid; Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown" and all described as "Was diagnosed with covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19, nasopharyngitis. It was reported that patient barely had any symptoms, cold symptoms, isolated for 10 days. The patient had his health having come in, and he thought he would just get blood check, to check out what he's doing and got an antibody infusion.  The lot number for bnt162b2 was not provided and will be requested during follow up.