chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at the vaccine site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had no side effects except soreness at the vaccine site for one day. Additional supportive information: The follow-up could not be possible as no contact details were available.
memory loss; shortness of breath; feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation; arm hurts; headache; heart keeps racing; heart rate is really high; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss), DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PAIN IN EXTREMITY (arm hurts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ischemia. Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, ALPRAZOLAM, ALPRAZOLAM (XANAX) and FLUOXETINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HEART RATE INCREASED (heart rate is really high) and PALPITATIONS (heart keeps racing). On an unknown date, the patient experienced AMNESIA (memory loss), DYSPNOEA (shortness of breath), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache). At the time of the report, AMNESIA (memory loss), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache) outcome was unknown and DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PALPITATIONS (heart keeps racing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes Hydrochlorizone , stomach pill as concomitant medication for unknown indication. Patient also take sucralaste for esophagus. Patient took Goodies Powder as treatment.
OVERDOSE; A spontaneous report has been received from a health professional. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced not applicable overdose (preferred term: Overdose).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Vax at 2:00 pm. Hives at 3:20 pm. Pt at ER stated that she exp SOB and that her tongue felt as though it were swelling.
Narrative: Pt 35 wk pregnancy w c/o some dizziness & SOB after received Vaccine. VSS @1542, B/P 111/59 P107, sat>97%, Temp 37C 2nd, b/P107/89 p 107/69, feeling much better after received snack/coolie & water, B/P stable 106/70 P103 left @1805
Pt. developed ongoing fevers from time of administration to time of evaluation in ED. Pt. also had vomiting and listless.
SEVERE FATIQUE(SLEPT 36 HRS-UP FOR ONE HOUR)-JOINT AND MUCLE ACHES,  TEMP 101.8,- HEADACHE LARGE RAISED HOT REDDENED AREA BELOW INJECTION SITE LASTING 5 DAYS THEN VERY ITCHY FOR 3 DAYS
Information has been received from a consumer concerning her niece with migraine who in 2009 was vaccinated with 3 doses of GARDASIL (lot # not provided). On an unspecified day the patient experienced a syncopal episode, the patient reported that she was seeing white spots and she could not see her. The consumer added "she could not see me and I was standing right next to her". Consumer reported that since receiving GARDASIL series the patient had experienced "severe" abdominal cramping. The patient was given a birth control pill (name unspecified) to treat the "severe" abdominal cramping but the "birth control pill" (name unspecified) had to be discontinued because the "birth control pill" caused the patient to become depressed and as a result of this depression she was admitted to a mental health hospital (name of hospital unspecified) for 3 days and was being followed by a psychiatrist and therapist (name unspecified). Consumer reported that the patient had been seen by a physician (address and phone number unspecified). At the reporting time, the patient had not recovered from the events. This is one of several reports received from the same source. Additional information has been requested.
Generalized  itchiness that started  on the day after the shot. It?s almost 6 days now and the itchiness did not go away. I have been  alternating Benadryl , Zyrtec and Pepcid Ac. Find relief from itchiness but did not completely went away. I only had one elevated  rash on my shoulder but went away next day. I also experienced diarrhea but it stopped after two days. The one that concerns me  the most is the prolonged itchiness .
The muscle In my left leg always bother me as it comes and goes after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose) 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 16-Apr-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 an unknown date, the patient experienced MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose). At the time of the report, MUSCLE DISCOMFORT (The muscle In my left leg always bother me as it comes and goes after the 2nd dose) was resolving.            No concomitant medications provided. No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up received regarding outcome.patient stated "I am much better now"Hence outcome updated as recovering/resolving from unknown
Expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Patient experienced hives that were isolated to the arm in which the vaccination was given. Area involved included shoulder, upper arm, and forearm to the wrist (no hand involvement). Additionally, the area surrounding the injection site about 2 inches in diameter also became hot, red, itchy, and hard (inflamed). PharmD did not personally witness the reaction. Per patient, her friend did personally observe the patient's reaction. Per patient, no other abnormal symptoms other than diarrhea the first two days following vaccination. Reaction was delayed until 6/16/2018 at approximately noon.
Dizziness, lightheaded; Stabbing headache; chills; nausea; lost of appetite; fever; fatigue; This is a spontaneous report from a contactable consumer (patient herself).  A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm (age at vaccination was 50 years old) on 24Jun2021 at 18:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient's concomitant medications included multivitamin. On 25Jun2021, at 12:00, the patient reported stabbing headache, chills, nausea, loss of appetite, fever, fatigue, diarrhoea, dizziness, lightheaded that is lasting now 18 days. The patient had no known allergies. It was unknown if covid was tested post vaccination. Patient did not receive any treatment. At the time of this report, the outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Simple spasms on shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Simple spasms on shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (Surgery done 10 years ago.). Concurrent medical conditions included Diabetes and Blood pressure. Concomitant products included INSULIN and METFORMIN for Diabetes mellitus.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-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 MUSCLE SPASMS (Simple spasms on shoulder). At the time of the report, MUSCLE SPASMS (Simple spasms on shoulder) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 antibody test: very little (Low) Result was very little.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included immunosuppressive drugs, novastic for blood pressure and cholesterol medication.  Treatment information was not provided.   This case was linked to MOD-2021-239400 (Patient Link).
Patient was supposed to receive the adult dose of Pfizer and received the pediatric dose instead.  County and state Dept of health notified along with parents.  Patient had no adverse reaction.
R29.810 LEFT FACIAL MUSCLE WEAKNESS 5/1/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
A report was received from a health care professional on 09/23/2002, concerning a female patient in her 60's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002, the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days spreading throughout the entire arm. On 09/23 the patient still experienced arm soreness. AT the time of the report the patient had still not recovered. The reporter has assessed the relationship of study medication to the event as possible and the helath care professional is concerned that the event may have been associated to the batch.
Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. No concurrent condition and medical history was reported. On 12-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry date: 14-JAN-2017, intramuscularly in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Chills, abdominal discomfort, headaches, heart abnormalities, odd thoughts
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 37 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
devel high pitch crying & fever lasting 4-5 hr nonstop crying; was seen by MD in ofc that evening; tx w/Motrin for fever & recommended DT for future vaccines;
This spontaneous report was received from a female patient of unknown age who is a nurse, via field representative. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced injection site reaction which included itching, injection site warmth and swelling. The patient did not sought medical attention. The patient was treated with ALEVE. The outcome of itching, injection site warmth and swelling was reported as recovering/resolving. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
pt received both vaccines in same  arm(left)  on 04/25/2022 by MA on 04/25/2022 per NP pt called to be checked on Friday after swelling  redness hard and hot to touch unable to know which one of vaccines gave this reaction.pt put on antibiotics for cellulitis  will check back if not resolved
pt recvd vax & immed following vax pt devel hives, inc BP & vomited for 3 hrs; pt recovered the following day; MD thought that pt's exp was the result of an anxiety attack; No further details were provided;
Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ.  The physician reported that a parent from his office refused ROTATEQ for their child because their friend's child was vaccinated with ROTATEQ and was hospitalized for Rota Virus.  Additional information has been requested.
Vaginal spotting and delayed period since the vaccine.  Constant pelvic and lower back pain since the vaccine.
Within 2-3 days I developed white painful sores in my mouth, on tongue, cheeks and in my throat. At first the doctors thought it might be a severe case of thrush so prescribed oral Nystatin which I tried for a week with no success. Then I was given an oral anti-fungal pill of Fluconazole plus an oral rinse that reduced inflammation in my mouth. It was severe for about two weeks before subsiding.
ulcer on tongue in mouth about the size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), MAGNESIUM, VITAMIN E NOS (VITAMIN E), MAGNESIUM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FOLIC ACID, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 12), MELATONIN, MELOXICAM, ALPRAZOLAM (XANAX), PRAVASTATIN, ESCITALOPRAM, CYCLOBENZAPRINE, HYDROCHLOROTHIAZIDE, METOPROLOL, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY + C), SALBUTAMOL (ALBUTEROL HFA), PROBIOTICS NOS (PROBIOTICS), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and DICLOFENAC (Pennasaid) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime). At the time of the report, TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Viscous Lidocaine Oral Solution. Concomitant medications includes singular.
Pt. took 1st dose of oral typhoid on 11/14/12 and 5 hours later developed severe abdominal pain. She took ADVIL and rested for 3 hours and the pain resolved.
heart failure; zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 78 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 15-SEP-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by a doctor in nursing practice for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: heart failure and other zoster-related conditions. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, heart failure was determined to be a medically significant event.
swelling; Chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), CHILLS (Chills) and NAUSEA (nausea) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), CHILLS (Chills) and NAUSEA (nausea). At the time of the report, SWELLING (swelling), CHILLS (Chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
No additional AE; patient was inadvertently given a dose of MMR II  after it suffered a TE; This spontaneous report was received from an officer manager referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters/ series (lot #U039907 with an expiration date on 16-DEC-2023), administered for prophylaxis (strength, and route of administration were not provided) after it suffered temperature excursion.  The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to a temperature excursion of 50 degrees Fahrenheit (°F) during a time frame of 0 hours, 36 minutes, 0 seconds.  No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA001807: US-009507513-2309USA001850:
pt recv vax & immed exp shivering & a painful burning @ inj site;also devel inc pulse over 100,dry mouth,trouble swallowing,lightheadedness,pain from the side of neck to elbow,& hives on neck & chest;recv no tx & recovered by evening;