chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increased redness; increased fussiness; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA103148 and 2020SA103147 via same reporter.  This case involves a 14 months old female patient who experienced increased redness and increased fussiness (erythema and irritability), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) ; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  The patient received 0.5 ml first and second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route at the left thigh for prophylactic vaccination on 19-Feb-2020 and 16-Apr-2020. Lot and expiry date powder and liquid vial was reported as UJ164AB,U6622AA and 16-Feb-2021, 16-Feb-2021).  On an unknown date, the patient developed non-serious increased redness and fussiness (erythema and irritability) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data were not reported.  Final diagnosis were erythema and irritability.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Systemic: Neurological Disorder (diagnosed )-Severe, Additional Details: 1 hour post injection patients right arm became paralyzed with excruciating pain/ patient had polio as a child and this was similar to what patient remembers experiencing as a child/had a neurology consult and is being treated with IGG treatments and is still under exam for ongoing symptoms and paralysis
Patient is 17 years old and 9 months, vaccine is currently approved for 18 and over. No adverse events were experienced. We spoke with both the doctor and patient's parents
Rash - face, arm and legs, itchy,a diffused red papular rash over face into scalp, upper arms, upper legs.
This spontaneous report as received from a consumer refers to her daughter, a 13 year old female. The medical history, drug reaction and allergies were reported as none. On 19-MAR-2013, the patient received "her first and last' standard dose of GARDASIL, via intramuscular. On 19-MAR-2013, immediately after vaccination the patient developed headache. This reaction was followed by nausea, vomiting, lightheadedness, severe stomach ache, until she was in tears. The patient also developed fever. The reporter explained that the patient developed these symptoms after being hit in the arm where she had received the vaccine. The patient told that the impact on her arm was the "strangest feeling that she'd ever felt". Therapy with GARDASIL was discontinued. No laboratory test was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention. The outcome of limb discomfort, headache, stomach ache, lightheadedness, nausea, vomiting, limb injury and crying were unknown. Additional information has been requested.
Flu like symptoms-sore throat, fever, chills, runny nose, cough.  Developed into a sinus infection.
This spontaneous report was received from a medical assistant refers to a 4-month-old patient. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. On 12-MAR-2018 the patient was vaccinated subcutaneously with VARIVAX (dose, units and frequency were unknown) (lot # N022995, expiration date 23-AUG-2019) which was reconstituted with sterile diluent (MRK INJ) (lot # N013283 and expiration date 03-OCT-2019) (drug administered to patient of inappropriate age). No adverse effects reported. There was no product quality compliant reported. No additional information provided.
Patient started feeling dizzy about 5-10 minutes after administration of the vaccine. EMS talked to her and she was doing a little better. She stayed in the pharmacy for about an hour and left with her mother to drive her home.
swelling arm; redness; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), ERYTHEMA (redness) and MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling arm), ERYTHEMA (redness) and MYALGIA (muscle pain). At the time of the report, PERIPHERAL SWELLING (swelling arm), ERYTHEMA (redness) and MYALGIA (muscle pain) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
sore throat; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender 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 OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment medication was reported.
HCP advised her to wait for 90 days to take the second dose; COVID-19; Sudden loss of taste; Sudden loss of smell; Malaise; Congestion of nose; Congestion of throat; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise) and NASAL CONGESTION (Congestion of nose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat) and FATIGUE (Fatigue). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Sudden loss of taste), ANOSMIA (Sudden loss of smell), MALAISE (Malaise), NASAL CONGESTION (Congestion of nose), OROPHARYNGEAL DISCOMFORT (Congestion of throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP advised her to wait for 90 days to take the second dose) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include asthma medicine. Treatment provided include, over the  counter pain and cold medicine. The patient was also quarantined due to COVID-19. Action taken with mRNA-1273 in response to the event; HCP advised her to wait for 90 days to take the second dose was not applicable.
Parent reported unconsolable crying for 2 hours at home on day of vaccination (4 hours after vaccination).
Fatigue, frequent illness requiring missing school, stomach upset - thyroid levels normal but feels worse than she did before she was treated for thyroid disease
Sore left arm; Rash on belly below breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on belly below breast) and VACCINATION SITE PAIN (Sore left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Rash on belly below breast). On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, RASH (Rash on belly below breast) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information include medication for thyroid and anxiety Treatment information not provided
This spontaneous report as received from a nurse refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on multiple unspecified dates, 5 unspecified patients were each administered improperly stored VARIVAX (Merck) injection, all from the same lot number and expiration date (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
A lot facial sensitivity on my right side of my face; Earache; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face), EAR PAIN (Earache) and HEADACHE (Really bad headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant) and HEADACHE (Really bad headache) (seriousness criterion medically significant). At the time of the report, FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face), EAR PAIN (Earache) and HEADACHE (Really bad headache) outcome was unknown.            Concomitant product use was not provided.  Treatment information was unknown.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
severe itching, swelling of orbital cavity & eyelids;recv DPH & hydroxine;
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
pt recv vax 9OCT95 & 17APR97 & devel a rash all over body;pt recovered;
This spontaneous report as received from a pharmacist refers to a 40 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately 2011 (reported as "5 years ago on an unspecified date"), the patient was vaccinated with his first dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). On 05-DEC-2016, the patient came to the pharmacy and requested the second dose of VARIVAX that was not administered. There was no adverse effect reported. Additional information has been requested.
Headache, chills, fever (99-100), muscle aches and pains, severe pain at injection site, dizziness, rapid heart beat. Symptoms lasted two days.
This spontaneous report was received from a registered nurse refers to unspecified patients of  unknown demographics. No medical history was reported. On an unknown date, unspecified number of patients were vaccinated with VAQTA (dose, route and frequency unspecified) which was improperly stored since 01-FEB-2014. No concomitant medications were reported. Nurse did not have any patient specific information. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additonal information has been requested.
Information has been received from a nurse concerning her 14 year old daughter who "months ago" was vaccinated with a dose of Gardasil. Approximately two weeks after vaccination, the patient experienced a "painful lump in her deltoid muscle". The physician reported that it "appears to be a hematoma". Unspecified medical attention was sought. The patient's symptoms resolved after a few weeks. Additional information has been requested.
Fluttering in chest. Heart Palpitations. Difficulty breathing. Waves of nausea and instability. Confusion.
Extremely sore arm, achiness on the entire left side, headache, chills, nausea
Patient came in to pharmacy 2 days after Pneumovax injection with chief complaint of two (2-cm) red spots near injection site and 2 (0.5-cm) red spots near wrist.
HEADACHE; INJECTION SITE PAIN; CHILLS; MUSCLE PAIN; TEMPERATURE CHANGE +2 DEGREES HIGHER THAN NORMAL TEMPERATURE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNWON expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) plus 2 degrees higher than normal temperature. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced temperature change +2 degrees higher than normal temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, injection site pain, chills, muscle pain and temperature change +2 degrees higher than normal temperature was not reported. This report was non-serious.
Four vaccine given on 5/24/2022.  Rash on face and upper body and sore throat and swollen gland in neck on right side.  Sore throat 1 week after vaccination(5/31/22) and rash 6/5/22.   Feeling tired and a lack of appetite currently.  Taking Tylenol and putting calamine lotion on the rash.
About 2 months after my vaccine, my menstrual cramps and side effects are much stronger than ever before. I had my gyno up my birth control dosage because my side effects were so strong. I get severe cramps and sore lower back when my period is about to start. I haven?t felt this pain since I was 16 and before I was on birth control. I did not think it was related to the virus until I have had several friends with the same side effect once after they got the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:  COVID 19 Treatment start date: 27Jun2022 and stop date: 01Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/27/21 presents to ED for "left shoulder pain" "more SOB on exertion". PMHx of "CAD, asthma, HTN, HLD"
Headache, Sedation, Myalgia, NauseaVomiting, Chills, Redness/Swelling/Itching/Rash @ injection site Narrative:  Other Relevant History:
Adjuvant not  reconstitutied with lyophilized component; Onlyliquid adjuvant portion administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) (batch number 99AG4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The registered nurse did not had expiry date on hand at the time of call. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up via email. Additional Supportive Information: The patient was administered the liquid adjuvant portion of Shingrix without reconstituting it with the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Persistent flares of whole body hives starting 9/26/22 (11 days post-vax). Continued despite initiation of prednisone on 9/28, still ongoing today 10/12
Immediate headache behind left ear in lymph node, fatigue and worsening headaches within 5 hours. Missed one week of work due to fatigue. Following week vomiting and diarrhea in addition to the fatigue. Abdominal pain. ER visit to rehydrate and evaluate.
Vaccine was expired for  4 days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
On May 21 woke up to heavy brown discharge. Went to ER on may 23rd . Having Cycles for 3 days . Off for week and return for 3 days . this happens every two weeks . also burning when urinating . Back pain all the time
received the 1st Shingrix dose in February 2020; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in February 2020).   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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient need to restart the series.
Vaccinated: 11/1/2021, 4/17/2021, 3/27/2021 Asymptomatic positive on hospitalization (unrelated to COVID) 12/23/21.
I developed shingles about a week after my first dose; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EI3247), via an unspecified route of administration, administered in Arm Right on 17Jan2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. No known allergies. There were no concomitant medications. No other vaccines taken in four weeks. No COVID-19 prior to vaccination and not been tested for COVID-19 post vaccination. On 24Jan2021, the patient developed shingles a week after first dose. The patient was reporting it because she had read some reports that this happened to others and there could possibly be a link. The patient visited a physician's office and was given antiviral and pain meds. The outcome of the event was recovering. The patient received the second dose of bnt162b2 (Lot number: EI9264) on 08Feb2021 in the right arm for COVID-19 immunization.
This isn?t really an adverse event for me, because I?m not trying to conceive, but it could be considered adverse for someone who is.  It seems that both getting Covid in my last menstrual cycle AND getting the vaccines during my current menstrual cycle  have caused really long cycles for me.  My cycle is typically about 30 days long and quite regular.   However, during my last cycle I had contracted Covid and the cycle length ended up being about 41 days.  And my current cycle is on day 56 and counting.  I just thought this was interesting to note, since my cycles are usually quite regular, and the only thing I can think of that has been different for me THIS cycle is that I got 2 Covid shots. I have had a tubal ligation, so it is highly unlikely that pregnancy is the reason for this unusually long menstrual cycle.  Just thought this was interesting to note and important to report.  Thanks!