chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lethargic; Low grade fever on at least three occasions; Tremors; Loss of appetite; frequent urination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 11:00 (Lot number: FE3590) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 15Sep2021. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDS". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Mar2021, when the patient was 67 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Lethargic"; PYREXIA (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Low grade fever on at least three occasions"; TREMOR (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Tremors"; DECREASED APPETITE (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Loss of appetite"; POLLAKIURIA (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "frequent urination". Therapeutic measures were not taken as a result of lethargy, pyrexia, tremor, decreased appetite, pollakiuria.  Additional information: Covid prior vaccination and covid tested post vaccination was reported as NO.  No follow-up attempts are possible. No further information is expected.
1 wk after vaccines, developed redness, swelling and itching at infection site on left Thigh. Redness has slowly spread over time. On 10-31-07 MD visit. 3.5 x 4cm, red, indurated over injection site. Adjacent and medial to site 8cm wide x 10cm long that is erythematous, indurated and warm. Diagnosed: Cellulitis left thigh - See attached MD office Notes for 10-31-07 and 11-2-07 ; "Patient" is a 2 year Old Female who presents today for evaluation of reaction to immunizations given 10/17 at health dept. She received DTaP #4, Varivax, MMR #2, and Hep #2, then a week later developed redness, swelling, and itching at the injection site on the left thigh. She received two vaccines on each thigh. She has had a subjective fever, and decrease in appetite, runny nose, but no other skin rash. The redness has spread slowly over the time. She never had a reaction to other vaccines in the past. Child not seen by PCP until 2 wks after injection. Mother hx said redness started wk after shots.
11AM Called to assess patient reports pre syncope in post vaccine observation area. Patient is stating that she is "lightheaded" BP 122/70, pulse 83, RR 16, provided with  Sprite and pretzels as patient states that  "this  has happened before after an injection." Presyncope resolved in 10 minutes and released. Instructed patient  to contact provider for follow  up. Patient verbalized understanding and dismissed at 11:50AM
No additional AE; HCP calling to report PROQUAD was administered 3 days prior to the patient's 1st birthday. No side effects were reported. No additional AE/no PQC.; This spontaneous report was received from a physician and refers to a 11-month-old patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent (STERILE DILUENT).      On 14-SEP-2023, the patient was vaccinated, at inappropriate age with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X007087 and expiration date 04-SEP-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Abdominal pain, loss of appetite, nausea and several episodes of vomiting starting 48 hours after vaccine and lasting over 10  days.
Shortly after vaccine my son had extreme pain in his chest and heart area. It expanded to his shoulder and part of his neck and could not stand up. We took him to the local hospital and after examination they said the blood work and ekg was fine so they released him. We are at home now and he feels the pain still if he pauses his breath, and he just showed me you can hear a very strange sound coming from his heart as it beats. I can hear it sitting near him a loud pumping or squirting sound in there as his heart pumps! Never heard anything like that before coming from someone?s chest!
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was date. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No Concomitant medication were provided No treatment were provided   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
at 1200, pt c/o "itching" at injection site "like a bee sting".  No hives, swelling noted.  Pt stated this is "how I feel when I have an allergy".  Stated she "takes benadryl" for this.   Observed.  At 12290, pt c/o "lower lip feels itchy".  Pt requested Benadryl; given 50 mg po Benadryl.  At 1245, pt stated she was feeling "better", elected to go home and left vaccination clinic.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Patient passed out 2 minutes after administering the vaccine. She was unresponsive and lost sphincter control. Epi-pen was administered at the same time emergency was called. Patient responded immediately after shot and was then laid out on the floor and vitals were taken.
Patient received 4th dose because she is immune compromised.  She should have received a booster dose, but she received an additional dose.
Dizziness, severe joint pain & swelling - stiffness - entire body - prednisone for 1 week. Good for a week then symptoms came back - not as severely.
Pt reports lg red area near injection site 2 days post inj. of Tdap, (+) itching (+) pain also c/o nurse from subq ZOSTAVAX.
I woke up at 4:30 am with Vertigo symptoms, dizziness, felt like I was spinning while lying flat in my bed. I felt nauseous, like I was going to vomit. I stood up to go to the bathroom and felt unbalanced. When I was sitting on toilet was coughing like i was going to get sick from spinning.  All symptoms got better after I ate, except that night and to this day (5/31) when I lay on my left side I get spinning feeling and then it does away.
Temp 102-103, inconsolable crying, intermittently calms down, resumes crying, high pitch approx exhausted & falls asleep 2 1/2 hrs later. Left clinic asleep. 1/6, re-evaluated, sx's now like croup & bilateral OM. Admitted, dx: croup.
Pt vaccinated with Meruvax II developed arthritis. Treated w/Azathioprine which caused neutorpenia. Plans to add gold therapy to treatment regimen.
Client reported lightheadedness, dizziness, blurry vision and diaphoresis.  Visibly pale.  V/S checked by onsite EMS.  BP 102/65, monitored for 10 minutes.  BP reduced, 108/84.   Monitored for 30 minutes.  Reported, "I feel normal."  Encouraged to follow up with emergency services and PCP as needed.  Verbalized understanding.
Second dose: trouble sleeping multiplied; First and Second dose: sore arm; Second dose: affecting everything, she is tired, tired, tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Lot number: EN6198) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL9269, left arm, Time 07:00), administration date: 12Feb2021, when the patient was 69 years old, for Covid 19 immunisation, reaction(s): "sore arm". The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: trouble sleeping multiplied"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "First and Second dose: sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: affecting everything, she is tired, tired, tired". The events "second dose: trouble sleeping multiplied", "first and second dose: sore arm" and "second dose: affecting everything, she is tired, tired, tired" were evaluated at the physician office visit.  Additional information: She used to be able to sleep 5-7 hours a night. She was having trouble going to sleep and staying asleep. She has been waking up every couple of hours, then she would go to sleep for an hour and wake up again. She was not sleeping well at all. 2nd dose was administered between 15:00-16:00. No other vaccine was administered on the same day and prior 4 weeks with the Covid vaccine.  No follow-up attempts are possible. No further information is expected.
dizziness and diaphoresis after vaccination, observation for 30 minutes and discharged home
Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: EW0178) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: bactrim. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Severe headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Patient developed rash (04/12/11) that spread to approximate 4 inch width with blister in center at vaccination site. It is painful to the touch but does not hurt.
The nurse verified a total of 9 administrations of improperly stored vaccines: 8 PROQUAD administrations and 1 VARIVAX administration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (0.5 ml, lot# T006792 and expiration date 24-AUG-2021; strength, route of administration were not reported) for prophylaxis (product storage error). The storage temperatures were -13.5 Celsius degrees for 24 minutes, -11.4 Celsius degrees for 27 minutes, -1.8 Celsius degrees for 2 hours and 8 minutes. There was previous temperature excursion. No product quality complaint (PQC) was involved in this case. Data logger was involved.  This is one of the 9 reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010334: US-009507513-2007USA010361: US-009507513-2007USA010374: US-009507513-2007USA010419: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010001: US-009507513-2007USA011962:
elevated thyroid; she had sore arm for a week and a half and a blister at the site of injection; she had sore arm for a week and a half and a blister at the site of injection; my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on unspecified date 2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2020 to an unknown date covid illness. Father had a history of Guillain-Barre syndrome. The patient's concomitant medications were not reported. On unspecified date 2021, it was reported that patient had bloodwork done which revealed elevated thyroid and that she had antibodies, after her first dose, she had a sore arm for a week and a half and a blister at the site of injection she also reports it ached by the injection site and my whole arm felt a little tight like a blood pressure cuff was on it for 4 or 5 days. The patient underwent lab tests and procedures which included blood work: elevated thyroid on unspecified date 2021, Blood work/antibodies (sars-cov-2 antibody test): she had antibodies on unspecified date 2021. Reporter assessed case as non-serious. The outcome of event was unknown for elevated thyroid and rest all recovered on unspecified date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient called today reporting a knot, pain, redness, swelling, some itching. Recommended she see a MD.
15 month old pt administered Kinrix; administered a dose of Kinrix instead of just a DTaP; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a 15 month old patient was administered a dose of Kinrix instead of just a DTaP dose ,which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. The reporter gave permission for follow-up.
8:30 am on 3/25,  Started feeling cold, then severe body aches?could hardly move I hurt so bad. Also had headache although not as severe as body aches and chills.  Ran temp of 101.5. Took  Tylenol but it didn?t do much. Fever broke at 2:00 AM Friday morning. Still felt light body aches when I got up Friday, but I was back to my normal self by noon on Friday. The day of side effects was brutal.
Information has been received from a Licensed Practical Nurse (LVN) referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 19-AUG-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J006140, expiry date 17-APR-2015)(dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
8 hours after the vaccine sensation of tongue swelling (not visible).  Tongue weird feeling since then.  Increase in frequency of baseline urticaria and angioedema.
similar reaction to first dose 1 month ago increasing altered mental status and generalized weakness with decreased mentation and talking starting one day after vaccine and requiring hospitalization 1 week later
After the vaccine I want to say around 12 hours later I experienced a fever, chills, I was shaking consistently , I had diarrhea for about 3 to 4 days after the vaccine . I had a fever of  102 .The following day the nausea that I started to experience  was horrific to the point where I felt like I wanted to vomit but  I just could not throw up, and  was also experiencing  fatigue and constant vaginal infections. I have had two periods and and nonstop bleeding after the second dose. I will be going to get an ultrasound next week in regard to what I experienced with the vaginal bleeding.
A few days after shot my whole body, including the site where the shot was given, became very itchy. I got a rash that started on 12/25/2020 all over my body and is still present as of today 01/04/2021.
Pt felt a hot flush and heart racing about 5 mins after vaccination.  BP 122/64, P 88-104, 96-99% O2 on RA.  Denied SOB, throat tightening, cough, swelling of lips, tongue or face.  Pt did become nauseous and had 2nd hot flush with HR going to 104.  Pt transported to ED for evaluation.
Left side of body became heavy, numb and tingly. Started in just left leg and progressed to left arm and hand. I was unsteady and was off balance. I fell twice.
On 12/20/2021 me, my husband, and daughter all started having symptoms. I was feeling achy and sniffly and we went and got tested on 12/21/2021 which was negative. I had body aches, a headache, sneezing, and sniffling, but no cough. 3 days later we tested again, and we all tested positive, and they told us to quarantine for 10 days. We all started feeling a lot better quickly. It lasted about 7 days. I am better and I was least affected with the symptoms. It did feel like someone beat me up and I had muscle aches, headaches, nasal congestion, fatigue, and tiredness.
First dose: Chest pain 5 days. SOB.  Second dose: Chest pain 3 days. Migraine 5 days. SOB 1 day.   Tx? None.
Information has been received from a published literature article. Introduction: Occult hepatitis B virus (HBV) was defined by the presence of HBV DNA in patient sera in the absence of hepatitis B surface antigen (HBsAg). Occult HBV had been associated with hepatocellular carcinoma, reactivation during immune suppression, and transmission to others. While the hepatitis B vaccine was very effective at preventing chronic HBV infection, recent studies indicated it was less effective at preventing occult HBV following infant vaccination. No studies, however, had examined the efficacy of adult HBV vaccination at preventing occult HBV. Here, it was presented the first report of occult HBV following adult vaccination. Case presentation: In November 2012, a 21-year old woman was admitted to a medical center with tricuspid valve endocarditis secondary to methicillin-susceptible Staphylococcus aureus which was complicated by non-ischemic cardiomyopathy (ejection fraction 15%). She reported active use of intravenous drugs. The patient tested positive for antibodies to the hepatitis C virus (HCV), with initially undetectable HCV RNA and subsequent low-level viremia. The patient was anti-HBs positive, anti-HBc negative, and HBsAg negative consistent with her reported history of prior vaccination with HBV vaccine (detail information unknown) as part of a nursing training program several years prior to her hospital admission. Despite a persistently negative HBsAg, HBeAg was positive, and HBV DNA was detectable in three separate serum samples. During the course of the hospitalization, the patient seroconverted to become anti-HBc positive. She received no antiviral medications and, at follow-up six months later, she was found to be HBeAg negative and anti-HBe positive, and no longer had detectable HBV DNA, indicating that her occult HBV infection had resolved. Conclusions: HBV vaccination in infancy was effective at preventing chronic HBV infection but was less effective at preventing occult HBV infection. Similar studies examining the efficacy of adult HBV vaccination in preventing occult HBV had not been performed. This case highlighted the importance of carefully determining the HBV status of high-risk individuals, as vaccination history and the presence of antiHBs might not be adequate to rule out HBV infection, even in the absence of HBsAg. Additional information has been requested.