chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-SEP-2023, the patient received Shingrix. On 25-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023. The reporter reported a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant. The reporter consented to follow up. The reporter did not provide patient demographics or lot number and expiration date.  No additional information was provided. The patient accidentally received a dose of Shingrix which had been reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
For 2nd COVID vaccine, I received chills, stiffness in shoulders and neck, aches and low-grade fever. This started the evening of 2nd vaccine and next day. Took Tylenol and slept. Was better 48 hours after 2nd shot.
Narrative:  Patient completed Moderna vaccination series on 3/15/2021. He received a third dose on 9/2/2021. He presented to the ED on 10/12/2021 with worsening COVID symptoms. He reported testing positive on 10/1/2021. Patient was admitted to the medical COVID Unit. He was treated with remdesivir x 5 days and dexamethasone x 5 days. He was discharged home on 10/16/2021.
HYPOTENSION ACUTE PULMONARY EMBOLISM 8/15/2022 -- RECURRENCE OF SAME SYMPTOMS
tested positive for Covid-19 (asymptomatic); tested positive for Covid-19 (asymptomatic); This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 (asymptomatic) on 13Jan2021. The pharmacist wanted to know if a person who was administered with the first dose of the Covid-19 vaccine on  administered on 04Jan2021 and on 13Jan2021 tested positive for Covid-19 (asymptomatic) and needs to quarantine can proceed with the second dose of the vaccine or if it's contraindicated. The pharmacist also wanted to know if it was okay to give the second dose as long as 90 days if a person with Covid-19 is deferred after recovering, and also asked when the second dose can be received if somebody did not recover fully from Covid. The outcome of the event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for Covid-19".
Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21.  Fatigue and body aches lasted the entire next day and resolved by the morning 1/15/21.  No fever
05/07/2022 started with allergy like symptoms: runny nose and sore throat. I tested positive with a at home test. On  Sunday I started having a headache, and I went to the ER that Sunday evening, 05/8/2022. They checked my vitals monitored me for a couple of hours  and gave me a prescription for antiviral medication specific for COVID-19.  I was discharged the evening of 05/8/2022. I tested negative by Friday, 05/13/2022.
Nausea/vomiting and dehydration. Treatment - antiemetics and rehydration.
Radicular pain in bilateral legs from hips to feet upon going to bed 10/28. These symptoms were gone 10/29 AM. Recurred Saturday night. Weakness in legs with trouble ambulating 10/30. Fell several times even with walker. Admitted to facility on 11/1/11 by his PCP. The weakness progressed to upper extremities along with some difficulty swallowing and decreased negative forced inspiratory numbers.
The first dose of the vaccine was taken on 03/03/2021 and the lot number is EN6202, and the second dose of the vaccine was taken on 03/24/2021 and the lot number is 03/24/2021. After fully vaccinated I was a little dizzy and a little nauseous those symptoms did clear up. I went to for the annual physical, with no symptoms, the doctors office did an EKG and found 3rd degree high blockage. the doctor suggested to go to a cardiologist. I did and the cardiologist performed another EKG and found the same results, 3rd degree high blockage. The cardiologist also had me wear a heart monitor for three days. I am wearing that until tomorrow. Last year my test wee almost perfect.
Normal resting heart rate is 65 bpm. Starting about 12 hours after vaccination, heart rate elevated to 100-110 bpm through the night. Same thing next night. Heart rate seemed to decrease if I sat up for a while. Was better by third night.
Information has been received from a registered nurse concerning a 23 year old female patient with penicillin allergy and with no pertinent medical history, who on 26-MAY-2010 was vaccinated IM with 0.5 ml dose of GARDASIL (lot number: 663559/1178Y, expiration date: 11-NOV-2011). Concomitant therapy included acetaminophen (+) diphenhydramine citrate ("Extra strength oral pack"). The nurse reported that on 27-MAY-2010 the patient developed stomach pain, dizziness, flatulence, diarrhea, nausea and heartburn. On 03-JUN-2010, the patient was examined in the physician's office and was prescribed ranitidine. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. Additional information has been requested.
The first 3 days I had initial nausea, then headache and fatigue.  The fourth day I felt better, then from March 8-March 12 I had nausea, a strange fuzzy feeling in my head, dizzy and lightheaded and fatigue.  I am able to work part-days but as of March 17, I am still having mild symptoms of slight nausea and feeling off.
Persistent chronic nonproductive cough without fever or other symptoms. The following prescriptions did not provide relief: Prednizone, two different antibiotics, Codeine cough syrup, Albuterol Sulfate inhaler, Benzonatate 100mg caps, Musinix DM, Musinix D, Bobutuson DM, and cough drops.
1836 Getting ready to release patient from post vaccination area and the patient stated that her left leg was numb. Her right leg was a little number. RR 16, 129/71, HR 64, spo2 100%, Patient says she feels nervous and was nervous about getting her shot too. Asked patient to walk around a little with assistance from her husband and she was notably limping on the left leg, no dizziness or other s/s noted. We advised her that we would wait a few more minutes to see how she feels. At 1849 the patient stood up with her spouse and said that the numbness was a little better and RN noted that she was walking better too. She left the clinic at 1849 with instructions to f/u with her doctor or go to ER if symptoms get worse. Verbal understanding received.
3+ pitting edema and tachycardia (114-140 beats per minute) Patient sent to emergency department for evaluation.   Recommendation for compression stockings
This spontaneous report was received from a registered nurse. The nurse reported that improperly stored GARDASIL (lot # not provided) many have been administered. No adverse event was reported. This is one of several cases from the same reporter. Additional information is not expected.
Information has been received from a health professional concerning a 60 year old female with diverticulitis, myalgia, and allergies to penicillin, codeine, doxycycline, CIPRO, and BIAXIN, who on 31-JUL-2007 was vaccinated intramuscularly into the left arm with a 0.5mL dose of PNEUMOVAX 23 (Lot# 655290/0959F). On 31-JUL-2007 the patient experienced some tenderness and pain at the injection site. The patient was examined in the office on 01-AUG-2007 and complained of injection site pain (painful to the touch), swelling, warm to the touch and redness. The patient also complained of fever and upset stomach. At the time of the report, the patient was recovering. The healthcare worker requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot# in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sore arm, headache,  blood pressure on meds normally 110 over 65, a few hours after vaccine blood pressure 145 over 64, fatigue,  all subsided after a few days, 1 week later hard lump at injection site about size of silver dollar that is red and itches.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 02-OCT-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004981, 1805USA004982).
Fever, body ache. treatment: Tylenol/ibuprofen PRN fever or pain.
VOMITING; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levetiracetam for seizures. On 21-MAY-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Became light headed within approx 5 min. It got worse and walking to observation room felt faint. Pulse rate elevated but attendant said not "critically high." Breathing was normal. After about 20 minutes I started feeling better. Oddly, while sitting in observation room, my sinuses cleared up, and I detected an odd taste at the back of my throat. Developed  frontal headache about same time; took acetaminophen and it went away after 12 hours.
patient reports painful swelling in the armpit starting the day after vaccination and lasting for a total of 2 days
This case was reported by a consumer (grandmother of subject) and described the occurrence of fuzzy in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; GlaxoSmithKline; unknown; unknown thigh given on 24 October 2012 at 10:00; unspecified vaccine; manufacturer unspecified; oral given on 24 October 2012. On 24 October 2012 at 10:00 the subject received the 1st and 2nd dose of PEDIARIX (unknown route, unknown leg) and experienced overdose. The subject "received two doses of PEDIARIX instead of one dose of PEDIARIX and one dose of HIB vaccine." On 24 October 2012, less than one day after vaccination with PEDIARIX, the subject experienced a "little fuzzy" and sleepy. The reporter consulted with the physician and the physician said that her grandson was going to be okay. At the time of reporting the outcome of the events were unspecified. No further details were available for reporting.
Patient reported that as vaccine was being administered there was vaccine running down her arm and pooled on the floor. Patient is concerned she did not receive the full dose.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES DERMATITIS (Herpes Outbreak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES DERMATITIS (Herpes Outbreak). At the time of the report, HERPES DERMATITIS (Herpes Outbreak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details were not reported by the reporter
Headache, nausea, chills, fatigue, for 3 days so far.
right ovary pain mild; nausea; arthritis pain on my feet; itching in the joints; I felt itching in the joints and swelling and heat.; I felt itching in the joints and swelling and heat.; I have arthritis pain on my feet on Saturday. It was so strong I couldn't walk.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 18Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included polycystic ovary syndrome (PCOS), possibly celiac and gluten sensitivity. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Jun2021 at 13:00, next day of vaccination, the patient experienced right ovary pain mild. On 20Jun2021, the patient had stronger pain in the ovary. On 21Jun2021, it intensified and had severe ovary pain plus nausea. The patient also had arthritis pain on feet on19Jun2021. It was so strong that she couldn't walk. The patient also felt itching in the joints and swelling and heat. Therapeutic measures were not taken as a result of the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, right ovary pain, nausea, arthritis pain on feet, itching in the joints, swelling and heat was not recovered at the time of this report.
Back inflammation 04/12/2021- present , UTI 04/12/2021- 04/18/2021Bladder infection 04/12/2021-04/18/2021, blurred vision 04/12/2021- present.
Numb Fingers on her Left hand (Not Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb Fingers on her Left hand (Not Injected Arm)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced HYPOAESTHESIA (Numb Fingers on her Left hand (Not Injected Arm)). At the time of the report, HYPOAESTHESIA (Numb Fingers on her Left hand (Not Injected Arm)) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.    Reporter did not allow further contact
Upper arm sore after shot.  Soreness subsided, now no pain at rest. Now, when lifting arm certain ways fell stiffness in arm at spot of injection. Patient has not seen a doctor regarding the issue.  Patient has not taken OTC medication for the stiffness
Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017c21a and 007c21a) for COVID-19 vaccination.     Concurrent medical conditions included Panic attacks (in treatment), Anxiety (in treatment) and Blood pressure high (occasionally take high blood pressure medication). Concomitant products included CITALOPRAM for Anxiety, METOPROLOL for Blood pressure management.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            No treatment details were reported.
Patient felt dizzy, passed out for few seconds and had a seizure likely activity and recovered well in the room, pt is sent to the ER and was discharge home from the ER
My face and eyes began to itch and look swollen a couple weeks after the second shot. I ignored them at first, but they got worse. I changed soaps and quit shaving, but that didn?t help. My face then quickly got red dots, and my eyes got multiple styes (two are large enough to be painful and obscure my vision). I do hot compresses daily, and the stye express pus when pressed daily. I?ve seen three doctors, I?ve been prescribed eight different antibiotic pills and topicals, and I?ve been told to hope it subsides in a few more months. And I?ve been adding vitamins/supplements. It looks bad and feels bad and requires daily maintenance. It also makes it hard to work on a screen all day. I never had any skin problems before in my life.
Hematoma; A spontaneous report was received from a 44-years-old, female pharmacist, who was also the patient, who received Moderna's COVID-19 vaccine and experienced hematoma.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in the back of her arm for prophylaxis of COVID-19 infection.  On 05 Jan 2020, the patient developed a hematoma at the site where the vaccine was administered. Treatment for the events included diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event hematoma was considered not resolved.; Reporter's Comments: This case concerns a 44 year old female subject who experienced a nonserious unexpected event of hematoma. The event occurred 9 days after first dose of the study medication administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
NSTEMI, new onset atrial fibrillation and congestive heart failure. Patient stabilized and discharged
pt recvd vax; apap given immediately p/ vax;approx 7:08pm 21oct94 started crying, high pitched & unconsolable x 3 hrs;
8 hours after receiving vaccines patient had a low grade fever to 100.4 and emesis. Over the next day fevers resolved, some emesis continued but patient started having looser stools. This progressed to copious, frequent watery diarrhea over the next week, ultimately leading to significant dehydration and requiring admission to the hospital for IV hydration.
505pm eyes began swelling while on way out of ofc. followed w/in minutes by rash on neck which spread to trunk 508pm.AP-160, HR-24, Epi given.510pm AP-148 pt calming.520pm Benylin given.BP palpated @ 60 syst.530pm Pt much better, acting nl
Pt was given HPV vaccine at 10:20 AM. 2-3 minutes after injection pt stood to walk out of room but c/o feeling funny. Pt was brought back to exam table at which at that time he fell back, and passed out, had a few convulsive movements, out about 30-60 seconds, woke up asking what happened, paramedics were called. NP and paramedics evaluated pt, decided ok. Sent home.
without reconstituting it with the lyophilized powder/no Ae; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who reported without reconstituting it with the lyophilized powder/no AE while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) , PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number unknown at unknown route in the unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.