chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 pts recvd dose of Engerix-B & HIB in same thigh & exp hematoma in thigh; No further details are available; This case is considered to be invalid;
Information has been received through the Merck pregnancy registry from a 41 year old female with no pertinent medical history and no known drug reactions/allergies, who on 19-FEB-2008 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659232/1514U). Concomitant therapy included Lexapro and levothyroxine sodium. On 10-MAR-2008, she discovered that she was 7 weeks pregnant. On 25-FEB-2008, the patient reported that she had an allergic reaction to something, and went to the emergency room department because she had "hives and itching all over her body". It was indicated by the patient that the hives went away. Laboratory and diagnostic studies were not performed. A quality complaint was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Information has been received through the Merck pregnancy registry  and from a physician concerning a 41 year old female with a history of 1 pregnancies (1 live birth and also a stillbirth or miscarriage) and no pertinent medical history and no known drug reactions/allergies, who on 19-FEB-2008 was vaccinated with a 0.5 ml of VARIVAX (Oka/Merck) (lot# 659232/1514U). Concomitant therapy included LEXAPRO and levothyroxine and prenatal vitamin. On 25-FEB-2008, the patient reported that she had an allergic reaction to something, and went to the emergency department because she had "hives and itching all over her body". It was indicated by the patient that the hives went away. On 10-MAR-2008, the patient discovered that she was 7 weeks pregnant. Laboratory and diagnostic studies were not performed. A quality complaint was not reported. Additional information has been requested. 6/18/10 Follow up information was received from a nurse. It was reported that the patient had a live birth and there was no indication of any birth defects. She stated that she had no further information on the baby. No further information is available.
soreness over first day, about 24 hours later patient passed out woke up on floor with severe damage to jaw and teeth, bruises to wrist and arms. Went to hospital for treatment. Has had surgery on 9/8/21.
2 AM chills, low-grade fever, headache, and body ache that lasted for 24 hours Fatigue lasting over 24 hours. Swelling in left armpit began 36 hours after vaccination
On 02/05/2023, I woke up and my heart started racing really fast. I got pain in my jaw and chest discomfort, shortness of breath. I put an oximetry and the pulse was low as 27/100. It did this for ten minutes then it stopped. I went to work and a nurse at work told me to go to the ER. I usually have a low pulse.  I went to ER but did not get treatment. On 04/11/2023, I was sitting in a meeting at work and my heart started beating really hard, they took my pulse and it was 122 and my blood pressure was 186/100 and I was sent to the ER. At the ER they did a heart catheter and they did not find any blockages. I am still having  alot of fatigue and light headiness. They put me on blood pressure medication.
Doctor would like for a 58 year old patient to receive Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in unapproved age group in a 58-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use in unapproved age group (Verbatim: Doctor would like for a 58 year old patient to receive Arexvy). The outcome of the off label use in unapproved age group was unknown.   Additional Information: GSK Receipt date: 15-NOV-2023 The pharmacist called to inquire if any information available as registered pharmacist mentioned that they had a 58 year old cancer patient and the Doctor would like for this patient to receive Arexvy which led to off label use in unapproved age group. The registered pharmacist confirmed that the patient had not been administered but they have a standing order of the vaccine for the patient and asked for guidance. The reporter did not consent to follow up.
Bump at injection site, itchy at injection site, raised rash at injection site, hot to touch at injection site - 8 days post injection
Moderna first dose.. At first I just had a few heart palpatations and felt off. After 3 days I woke up with pain in my right side and down leg. I then got a rash on my right butt cheek. Turned into Shingles. I have had shingles in the past but it was over a year ago.
This spontaneous report as received from a certificate medical assistant refers to a unspecified number of patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date, the patients were vaccinated with doses of incorrectly storage (Oka/Merck) VARIVAX (doses and routes were not reported) lot # K002928 expiration date 26-FEB-2016 and lot # K005429 expiration date 15-APR-2016. No adverse effects reported by any patient. Secondary suspects and concomitant therapies were not reported. Additional information has been requested. This is one of several reports received from the same reporter.
Febrile seizure - 1/22/07 lasting < 5 min.  -> ER visit, no labs, observation, education & D/C'd home.  (Had second febrile sz. 6/24/07).
Got shingles for 6 weeks; Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got shingles for 6 weeks), PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) and RASH (Rash all over body) in a 59-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Got shingles for 6 weeks), PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) and RASH (Rash all over body). The patient was treated with DOCUSATE SODIUM (LAXADINE [DOCUSATE SODIUM]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Got shingles for 6 weeks) and PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) had resolved and RASH (Rash all over body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took concomitant medication which were not specified by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received contain an adverse event such as shingles and its outcome  to recovered/ resolved.
doesn't feel good; fever; nausea; feels lightheaded; feels generally crappy; has some swollen glands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Sep2021 (Lot number: FC3184, Expiration Date: 31Oct2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Diagnosed 3-4 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, Lot Number: FC3181, Anatomical Location:  Injection; Right Arm), administration date: 29Aug2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "doesn't feel good"; PYREXIA (non-serious) with onset 20Sep2021, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 20Sep2021, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset 20Sep2021, outcome "not recovered", described as "feels lightheaded"; FEELING ABNORMAL (non-serious) with onset 20Sep2021, outcome "not recovered", described as "feels generally crappy"; LYMPHADENOPATHY (non-serious) with onset 20Sep2021, outcome "not recovered", described as "has some swollen glands".  Additional information: Prior vaccination (within 4 weeks) no any other vaccine administrated. Adverse event prior vaccination was none.   No follow-up attempts are possible. No further information is expected.
Heart palpitations beginning about 10 days after injection and increasing in frequency and intensity for several weeks. Then occurring at several an hour as a big "thump" for several weeks, and then gradually decreasing - first the intensity reduced, then the frequency reduced. Whole duration of increase and reduction being approximately 4 - 4 1/2 months, and, I still get them occasionally, but with way lesser intensity and frequency.  Major league joint pain beginning about 2 weeks after injection (I have had arthritis in my hips for over 20 years) in both hips, both knees, back, and hands. I tried every normal remedy including OTC pain medicine, heat, cold, creams, acupuncture, diet and lifestyle modifications, etc. I was unable to to anything without significant pain, including sleep. Lack of sleep made it all worse. It kept getting worse and worse especially in my knees and hips  until I ultimately went to see my doctor. She examined my knees and caused me considerable pain during her hands on examination. Recommended x-rays which did not show arthritis to the extend she would have expected from my demonstrated pain. And then it started to abate as well. Duration of agony was about 6 months. Now, with any insult to my immune system, it flares up again.
29may90 pt vax hepta B.  pt devel itching, followed by hive like welts. devel dermographic sx, and perineal burning for aprox. 30 sec.
Systemic: Headache, Systemic: Eyes dilated and difficulty remembering information; symptoms lasted 2 days
they received the GARDASIL 9 vaccine at 16 weeks; no additional adverse event reported; wrong vaccine administered; This spontaneous prospective pregnancy report was received from a 34-years-old female patient, referring to herself.      The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided. Her last menstrual period was on  02-JUL-2020.   On 23-OCT-2020 , the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) instead of flu vaccine (dose, frequency, lot# and expiration date not provided); at the time of the vaccination the patient was 16 weeks  pregnant, she referred that the baby is due 08-APR-2021. She reported not side effects that she was aware of. The pregnancy outcome was outcome pending.
Breakthrough case admission after 4 vaccines MOderna 1/18/21 Lot# 011L20A;  Moderna 2/15/21 Lot# 016M20A;  Moderna 9/4/21 Lot# 018B21A;  Moderna 6/2/22 Lot# 059M21A
weakness, buzzing in head,faintness-dec in 1/2hr;next AM, strong neurological rxn in head, trunk & arm pain, difficulty breathing, head squeezed, ears clogged w/ringing;weakness & fatigue;flu like sx;faint, body pain, intestinal problems;
DIZZY; ARM A LITTLE SORE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, hydrochlorothiazide for blood pressure, losartan for blood pressure, and prednisone for sinus infection. On 11-APR-2021, the subject experienced arm a little sore. On 14-APR-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and arm a little sore. This report was non-serious.
1st dose:  I was lethargic, confusion, weakness, tiredness, wanted to sleep 2nd dose:  Same as above but it lasted longer, all the above symptoms were getting worse.  I was confused, felt fearful to drive or to go anywhere.  Developed 2 UTI's (not sure if related) but I have not had a UTI since I was a child.  Ended up in the hospital due to weakness in my legs, depression (which I do not or ever had) They treated me with IV antibiotics and ran every test they could and could not find anything.  They had no answers as to if I had an allergic reaction to the vaccine, nor did they want to talk about that.  I was in for 4 days.
Information has been received from a certified medical assistant (C.M.A.) concerning a 12 year old female with haemorrhoids and no drug reactions/allergies who on 26-FEB-2007 was vaccinated with her first dose of GARDASIL. In 2007, "sometime in the past couple of months", the patient developed blood in her feces. The C.M.A. believes that it is the result of her hemorrhoids. On 14-NOV-2007 the patient will receive her second dose of GARDASIL. As of 14-NOV-2007 the patient had not recovered. Medical attention was sought in the office. The product quality complaint unit was not involved. Additional information has been requested.
Low fever, headache, itching & sore throat, cough, runny nose, wattery eyes. Symptoms begun 5 days after vaccine and last 5 days until today. This symptoms are more severe during afternoon and night. I feel better during morning, just snneezing.
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 1 year old male patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Rt deltoid arm red swollen hard. Mom states redness measured 5 inches and has pictures on digital camera at home. Redness resolved Sunday. Fever started late evening and broke Saturday 104.3- Sunday 99.8. Mom called Dr and gave pt tylenol alleve with Ibuprofen.
Narrative: Patient received the vaccine on 4/6/21 and subsequently had a fall on 4/9/21 that required 911 to be called and taken to ER where they administered a tetanus shot and sent him home. On 4/10/21 the patient passed. The patient had several comorbid conditions which included to but not limited to diabetes, carcinoma of the bladder, Stage 4 chronic kidney disease, pacemaker, atrial fibrillation, COPD, hypertension, and amputation above the knee of one leg.
Case number PHHY2012AU053470 is an initial literature report received on 20 Jun 2012: The authors presented a case of acute ataxia syndrome associated with H1N1 2009 influenza vaccination. This report refers to a 30-week pregnant 37-year-old female patient. She was vaccinated with a pandemic H1N1 influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Fourteen days after vaccination she developed an acute ataxia syndrome. On examination, there was horizontal opsoclonus (ocular flutter) and disrupted smooth pursuit in the horizontal plane. There was marked dysmetria in the upper limbs and broad-based ataxic gait. The patient exhibited tremor and myoclonus, and the remainder of the examination was normal. MRI (magnetic resonance imaging) of the brain and spine was unremarkable, as were serologic investigations for infective etiologies. A diagnosis of opsoclonus myoclonus syndrome was made and methylprednisolone was administered intravenously for five days. Symptoms improved and had resolved by day 14 of her illness. The authors commented that while definitive identification of antecedent causes was usually not possible in this condition, the temporal association and exclusion of alternative etiologies raised the possibility that this patient's neuroinflammatory disorder might be related to H1N1 2009 vaccination.
On 6/5/08 - reddish rash/bump appeared around site of injection.  Rash lasted for 1 week.  Rash starting to go down on 6/12/08.
Shaking from chills, Diarrhea, vomiting, sweats, headache, body aches, slept 36 hours Finally better Thursday noon 11.19.2020
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 21st August 2018). On 3rd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd March 2019, 4 hrs after receiving SHINGRIX, the patient experienced vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased and drug dose administration interval too long. On 4th March 2019, the patient experienced hives and red face. On 13th March 2019, the patient experienced visual disturbance. On an unknown date, the outcome of the vomiting, chills, fever, injection site pain, headache and urinary incontinence were recovered/resolved and the outcome of the diarrhea, gastroenteritis, tiredness, swelling arm, hives and red face were not recovered/not resolved and the outcome of the injected limb mobility decreased, visual disturbance and drug dose administration interval too long were unknown. It was unknown if the reporter considered the vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased, hives, red face and visual disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving 2nd dose of the SHINGRIX vaccine, the patient vomited 7 times and had fever, swollen arm, pain at injection site, chills, diarrhea, uncontrolled urine, tiredness and headache. The patient had difficulty moving her arm around. Next morning (4th March 2019), the patient's left side of the face broke out hives and redness. She went to her doctor on Monday afternoon and she was diagnosed with gastroenteritis. The patient was still experiencing diarrhea, tiredness, swollen arm, redness and hives on the face. The vomiting, fever, pain at injection site, chills, uncontrolled urine and headache lasted for about 9 days. On the day of reporting, the patient experienced lightening aura in her eyes. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
Med error. Wrong vaccine given. Pneumovax ordered Prevnar 13 admin. by mistake
Pain at injection site for 24 hours. Then 9 days later a rash started developing below the injection site. No pain, but woke up to dull pain in left arm on day 10
24 hours following injection of Hepatitis A vaccine, employee reported high fever, dry heaves, loose stools and lack of appetite. Unable to report for duty because of this illness.
Patient was vaccinated on 1/22/2021 and 2/12/2021 and had out of hospital cardiac arrest on 5/5/2021 where he was tested for COVID-19 and was positive.  He had previously tested negative on 4/19/2021.
Within a few hours of injection, I noticed a rash in the lower middle of my back. The next day, the rash had spread to the midsection of my body. Rash are red with small blisters. This is day 3 of the injection and the rash remains.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date of 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Significant pain and edema to right arm, shoulder, and extending to clavicle. SOB. Fever. Required bronchodilator and pain medication. Xray of humerus as precaution. Treated in clinic 10/6/16 and ED 10/7/16.