chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a cold, little bit cold; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11May2021, outcome "unknown", described as "I have a cold, little bit cold".  Additional information: patient would like to report that, he currently had this cold and then he was due to get his second dose by the day after the present report (22May2021). Other question he had, if it was okay for him to get the second dose tomorrow even though he was experiencing that type of adverse event something like that. Patient had a cold, little bit cold. It started on 11May2021. He took vaccine first dose on 01May2021 but the cold started on 11May2021 or something on that prior week (as reported) and he still felt it little bit but he just wanted to say whether he had to go for the day after dose or he needed to stay until he fully recovered from that. He stated, "no mam sorry I mean".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/11/06 at 11:05AM, Influenza injection-Needle Stick - Distressing, Plunger Pressing - Very Distressing, Within the next 8 Hrs. Very Intense Pain from Shoulder to Finger Tips, Within the next 4 Hrs. Excruciating Pain from Shoulder to Finger Tips and could not lift left arm.10/12/06 at 3:00AM went to ER for evaluation and the Dr prescribed medication and advised me to see Orthopaedic Doctor ASAP for evaluation. 10/17/06 saw Dr. for evaluation, Shoulder X-ray and he prescribed medication. 10/31/06 saw Dr., MRI and he reported results to Dr. 11/27/06 saw Dr., Neurologist evaluation and prescribed medication and said he did not know what was wrong with my shouder, also Dr., EMG evaluation and reported to Dr. 02/07/07 saw Dr., Neurology Physical Thearpy for six weeks. 03/21/07 Dr., Pain Clinic Stellate Ganglion Injection. 04/25/07 Dr. said she could not help me and recommended that I see  Dr.,   Orthopaedic for Evaluation/Joint Injection he concluded that my Shoulder injury was caused by the influenza injection that I needed to see another Doctor to help me with this type of injury which was beyond his expertise. Curently, my pain level for the past three weeks has been excruciating and I have been unable to function independently. I need some medical help but I don't where to go now. Thank you
Started having hallucination; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  Medical history included unknown pre existing medical condition. Concomitant medications were not provided.  On 05 Feb 2021, approximately nine days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Feb 2021, 2 weeks after first  vaccination dose (on 14 Feb 2021) the patient had hallucination and was hospitalized, she had history of recent hospitalization on 26 Jan 2021 prior to vaccine administration but the details were unknown. The reporter was also concerned about her mother receiving the second dose of vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, hallucination was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Large red circle at injection site appeared yesterday. The area itches and is warm/tender to the touch.
3-4 CM X 5 CM WARM, INDURATION, SWOLLEN AREA TO THE RIGHT ANTEROLATERAL THIGH.
Maternal exposure during pregnancy; Other high risk HPV genotype pool positive; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jul-2021, the patient experienced PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, PAPILLOMA VIRAL INFECTION (Other high risk HPV genotype pool positive) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Human papilloma virus test: Positive.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant and treatment medications were not provided.  Degree of severity for the event was reported as Grade 1: Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, no intervention indicated.  Summary of the event was reported as Cervix: acetowhite lesions noted at 9 o'clock, no biopsies taken.  Company comment: This spontaneous case concerns a pregnant female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Papilloma viral infection which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Acetowhite lesions were noted at cervix 9 o'clock. Biopsy was not taken. Event was ongoing at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a pregnant female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Papilloma viral infection which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Acetowhite lesions were noted at cervix 9 o'clock. Biopsy was not taken. Event was ongoing at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fallen twice; Severe dizziness; A spontaneous report was received from a consumer concerning a 79-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe dizziness, fallen twice/ fall.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event severe dizziness. On an unknown date, the patient experienced the event fallen twice.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events severe dizziness, fallen twice was unknown.
Extremely hot and tired, migraines, nausea (for 5 weeks), tightness in chest, throat closed up twice, face rash, joint pains, shooting and cutting pains in areas of surgery and injury: left hip, right shoulder, vagina. Felt out of it
Patient is fully vaccinated.  COVID + 1/15/2022 on admission to hospital.  The patient is a 73y.o. female with history of COPD, DM, CAD wh presents with a complaint of abdominal pain and rectal bleeding. Hg 7.7.  Also noticed nausea, vomiting, and loss of appetite. No fever. Patient also has had a cough in the past 4 weeks with mild sputum production and no shortness of breath. Treatment: albuterol. Stablized and discharged.
patient was diagnosed with bilateral pulmonary emboli within 3 weeks of vaccine administration, developed dry cough within 1 week of vaccine that progressed to worsening shortness of breath.
On  June 5, 2022, I tested positive for Covid.  I was prescribed molnupiravir 200 mg 4 pills every 12 hours for 5 days starting on June 7, 2022.  I had very mild cold symptoms.  The only reason I tested myself is because my husband had covid. Around the same time, I started to experience pain and stiffness in my knees and ankles and some pain in my hands and shoulders.  In July, I was found to have an elevated sedimentation rate (48), an elevated uric acid level (8.2), and  an elevated c-reactive protein (18.6).  I was given meloxicam which lessened the joint symptoms somewhat.  In September, I was given prednisone which had no effect after two weeks.  I am now on methotrexate and colchicine and have noticed little change after about a month.
Noticed edema and tingling of "pins and needles" of right arm. The following day symptoms have changed to include numbness of the entire right hand with loss of strength and sensation.
Inappropriate schedule of Vaccine/has not received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter had nothing else to report.
This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
given an expired Menactra vaccine to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other health professional This case involves a patient of unknown age and other health professional reported that given an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine to a patient (expired product administered), (batch number: unknown and expiration date: unknown) for prophylactic vaccination.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to the expired vaccine used (latency: unknown).  At the time of reporting, the patient had no adverse event.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available regarding batch number in this case.
Dizziness, achy at injection site, total body aches, chills, hot spells, break out on mouth.
Tight cough with itching. Epi given, transported to hospital VS- BP 138/84 P 88 R 20.
Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs.
May 18th I was out of state, everyone I was with was reacting to the pine pollen. Overnight I could feel it going into my bronchiole tubes, I was developing a bad cough. I was coughing up mucus that was dark green. I went to a clinic. They did a COVID test. The doctor confirmed it was bronchitis, he prescribed a steroid and a decongestant (5 day course for each).  I was very tired, physically and emotionally. It took 3 weeks for me to get rid of the bronchitis. Six weeks later after bronchitis, my voice has finally came back.
sore arm; upset stomach; nausea; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            The patient reported that he had an increase in his PSA level (details not provided). He wanted to confirm if he could take Tylenol for his symptoms? Concomitant medications and treatment details were not provided.
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in cases: 2014SA071241, 2014SA071260, 2014SA071262, 2014SA071266 and 2014SA071268. A 5-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
after vaccination had pulsating heartbeat in left ear, same side as administered shoulder. 5 weeks later took Excedrin migraine as recommended by doctor and went away. two days later had pain on left side of face, ear, throat and neck. now have severe neck pain, throat on left side and ear pain in that ear. put on steriod methylprednisolone to see if it helps.
MMRV and Varicella were given on same day and were given IM instead of SQ.  Child was brought to clinic 2 days later as a precautionary measure for a follow-up visit.  Child was asymptomatic.  No problems reported by parent.
Symptoms began with what seemed to be a very bad cold that did not go away: cough, sore throat,  congestion, sneezing, stuffy/runny nose, cold sweats/low grade fever, headache, lethargy. By December 2017 myself and ten year old daughter were diagnosed with Pertussis (Whooping Cough)
Patient developed a patch of hives that was warm to the touch 1 and 2 inches below the injection site on Wednesday 1/23/19. There was no reaction at the injection site. Then on Thursday, January 24th patient developed swelling from the base of her neck to her shoulder. She went to Urgent Care and was prescribed prednisone 20mg: 2 qd for 5 days.
A patient had vaccinated with the wrong diluent for ActHIB and used the diluent used for MMR, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00493679) and transmitted to Sanofi on 25-Feb-2021.  This case involves a patient (unknown demographics) who had vaccinated with the wrong diluent for and HIB (PRP/T) VACCINE [ACT-HIB] and used the diluent used MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (not produced by Sanofi Pasteur) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product preparation issue).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The doctor stated that she had patients waiting so this is all the information she provided at the time of her call but she indicated that safety could follow up with her in terms of a phone call or something in writing.  This was a case of actual medication error due to inappropriate dilution of medication (latency same day).  At the time of reporting, no adverse event was reported.  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.  There will be no information available on batch number for this case.
A report has been received from a Health Professional concerning a 19 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on 14-AUG-2013. The patient experienced enlarged lymph node left armpit which started on 16-AUG-2013. At the time of reporting, the event of enlarged lymph node left armpit was improving. The report was considered to be non-serious by company physician.
Information has been received from the Nurse Practitioner concerning a 61 year old female patient with non drug reactions/allergies reported and history of problems with her right knee, who on 12-JUL-2010 was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (route unspecified and Lot number: 663891/0509Y). Concomitant therapy included amitriptyline hydrochloride (manufacturer unknown) and "galapenein". The Nurse Practitioner reported that the patient "is going for shoulder surgery". The Nurse Practitioner did not know if the consumer had a shoulder problem before or after getting PNEUMOVAX 23. No laboratory test was performed. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. The physician did not feel the weakness in the leg was associated with PNEUMOVAX 23. Upon internal review the patient "is going for shoulder surgery" was considered an other important medical event. Additional information has been requested.
1659 Patient was kind of touching her chest and looking a bit nervous, so  manger asked her if she was okay. she said no that she was having a little tightness in her chest but not difficulty breathing. States has been for the last 5 minutes. Feels nervous. 1703: HR 95, BP 134/70, spo2 100%, rr 18. Has a hx of anxiety but is not scared of needles. Claims she and her partner both got COVID in July 2021 and received monoclonal antibodies on August 2nd and that is why she came in today to get vaccinated. RN asked her what kind of symptoms she gets with her anxiety, she stated chest pain and difficulty breathing. Still not having any SOB. Allowed patient to have some water and rest for a few more minutes. 1716 HR 94, BP 122/70, spo2 100%, rr 17. Patient states that she feels better she is just hot. Patient left with significant other at 1520.
Case number PHEH2012US015691 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 13-year-old patient of unspecified gender. This patient was vaccinated only with MenCYW-135 liquid component of MENVEO (batch number M11033) without being reconstituted with Men A component of MENVEO on 29 Jun 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.; Room temperature for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 28-Mar-2021 and Pfizer vaccine on 19-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 15-Feb-2022 at 12:29 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial had been left at room temperature for more than 24 hours. The vial was removed from the refrigerator at 8:12AM yesterday and was administered at 10:21 AM, 10:34 AM, and 12:29 PM.) and PRODUCT STORAGE ERROR (Room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No reported symptoms, no additional doses stated  by  the patient . Concomitant medications was not reported.  Treatment medications was not reported.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On 27-SEP-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength, dose, route of administration were unknown) with lot # R002507 and expiration date of 25-JAN-2020 for prophylaxis which was stored from 6 Fahrenheit degrees (°F) to 14 °F for 30 minutes and was determined due to a data logger. There was no previous temperature excursions. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1809USA013613.