chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  The last time I took a flu shot I got the damn flu and never had it b4 the shot.   Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event.
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided   Reporter did not allow further contact
The rash is described as moderately pruritic and markedly sensitive to touch. Warmth and tenderness surrounding injection site w/ o appearance of cellulitis.
Generalized itching and hives developed 1-2 days after vaccination with Shingrix. 7 days after itching/hives began occured, pt went to ER for examination. ER physician diagnosed with hives. Given parenteral antihistamines and instructed to continue PO antihistamines at home and topical steroid cream. At day 8 since symptoms began, hives are beginning to diminish, though itching remains present.
Information has been received from a nurse practitioner concerning her approximately 28 year old daughter with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated IM with the first 0.5 ml dose of GARDASIL. No concomitant medication. Within 4 to 6 hours after receiving vaccine the patient developed moderate to severe rectal bleeding which lasted 4 to 7 days and went away. However, 3 weeks later the rectal bleeding occurred again but then went away after a few days. Sometime in February 2011 the nurse practitioner's daughter received the second dose of GARDASIL and within 4 to 6 hours she developed rectal bleeding again which lasted 4 to 7 days. On 21-FEB-2011 she had a colonoscopy and at that time there was no active rectal bleeding. The colonoscopy did not reveal anything. Results were normal. The patient did office visit to a gastroenterologist and the gastroenterologist thought the rectal bleeding was from the GARDASIL. The daughter described the bleeding as "blood pouring into the toilet". No treatment was given. Lab test for anemia was performed (result not reported). The daughter had decided not to receive further doses of GARDASIL. Vaccine of GARDASIL was discontinued. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
I started getting symptoms of a cough. The next day, I had heavy congestion, nasal discharge, headache, and fatigue. My blood pressure also went up to 140/100 even with medications. I contacted my doctor. I went to an urgent care drive thru test and I took a PCR and rapid COVID-19 test which indicated positive. These symptoms are still ongoing.
headache with pressure, shoulder pain, arm pain on injection site with tenderness and warmth to the touch, nausea, woozy and lightheaded.  Took Tylenol for the pain. Arm pain, tenderness and warmth are still active today 1/21/21, all other symptoms only lasted the day of the vaccine until around 7pm.
Pt felt dizzy after 2nd HPV. Layed pt down 10 minutes pt felt better and was discharged.
Information has been received from a physician concerning a 31 year old female with asthma who on approximately 01-APR-2008 was vaccinated with a dose of PNEUMOVAX (dose, route and lot # not reported).  On an unspecified date the patient developed a cellulitis after vaccination with PNEUMOVAX.  The physician did not treat the patient for the cellulitis, and did not have information about its time frame development or resolution.  The patient went to the emergency room and was told that the cellulitis was caused by a "Staph infection."  The emergency room physician (name unspecified) told the patient that her arm was not properly cleansed prior to vaccination.  Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Severe chills, nausea, fever, severe body aches, sore arm for several hours the night of receiving the vaccine. Was feeling better the following morning.
mild headache and then went away; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Insomnia on 20-Oct-2015. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015 and Restless leg syndrome since 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date and LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 25-Feb-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (mild headache and then went away). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. In 2021, HEADACHE (mild headache and then went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) POSITIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348352, MOD-2021-348434 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-oct-2021 Patient demographic details added, Medical history with start date added, Suspect anatomical location added,Concomitant medication with indication, Dose,Route added, Event start/stop date for third dose added, newverbatim added for event headache (PT) and intensity of event updated from mild to severe for 3rd dose event
ALMOST TOTAL LOSS OF HEARING THAT CAME BACK; SHOOTING PAINS UP RIGHT LEG; TOTAL BLACK OUT OF VISION WITH A WHITE WINDOW THAT TURNED YELLOW BEFORE VISION RETURNED; NUMBNESS THAT COMES AND GOES; SHOOTING PAINS OUTSIDE OF BRAIN; EXTREME SORE THROAT FELT LIKE RAZOR BLADES; FELT SQUEEZING WINDPIPE; RINGING IN THE EARS THAT COMES AND GOES; BLURRED VISION THAT CAME BACK QUICKLY; SHORTNESS OF BREATHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced shortness of breathe. On 11-APR-2021, the patient experienced blurred vision that came back quickly. On 15-APR-2021, the patient experienced ringing in the ears that comes and goes. On 15-MAY-2021, the patient experienced extreme sore throat felt like razor blades. On 15-MAY-2021, the patient experienced felt squeezing windpipe. On 18-JUL-2021, the patient experienced shooting pains outside of brain. On 18-JUL-2021, the patient experienced numbness that comes and goes. On 04-AUG-2021, the patient experienced total black out of vision with a white window that turned yellow before vision returned. On an unspecified date, the patient experienced almost total loss of hearing that came back, and shooting pains up right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pains up right leg, was recovering from almost total loss of hearing that came back, extreme sore throat felt like razor blades, felt squeezing windpipe, and blurred vision that came back quickly, and had not recovered from shooting pains outside of brain, ringing in the ears that comes and goes, total black out of vision with a white window that turned yellow before vision returned, shortness of breathe, and numbness that comes and goes. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
first dose given in FEB, can second dose be given or repeat both doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose given in FEB, can second dose be given or repeat both doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose given in FEB, can second dose be given or repeat both doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose given in FEB, can second dose be given or repeat both doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported. No concomitant medications reported.
3mins after vaccination pt had a syncopal episode.  Pt was wheeled to the area while continuously observing pt.  Pt awake and oriented/alert. Pt given juice. Vitals: 131/70, 85, 20 O2 100% -- > 117/60, 71, 100% Pt stable and release from the vaccination site.
First of all the shot itself hurt, injection hurt and my arm was VERY sore from the moment the needle hit me till about 48 hrs. later. About 6-7 hours after getting the shot I felt chills, muscle aches and headache. The next day I had a fever of 101.5, plus all the previously mentioned symptoms. Very dizzy all day and a little nauseas. All I could do was lay in bed, drink fluids and I took Tylenol mid day on 5/8/21. The Tylenol seemed to help me sleep and my fever came down to normal range, but then my kidneys and liver started hurting that night and the next day. Symptoms continued until late on 5/9/21. By 5/10/21 I feel basically normal.
Pt had a low grade fever 9 days after receiving the vaccine. Lasted for 1 day.
swelling, bruising, pain x 1 wk at site of injection, no fever.  Most likely hematoma
A red colored rash developed  on inner thighs with 24 hours of injection.  There was mild itching; rash resolved itself the following day.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (doses and routes were not reported) lot # H021608, expiration date 13-AUG-2015 and lot # K006117, expiration date 14-JAN-2017, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Numbness, burning sensation at injection site down B/L arms within hours after vaccine, next day down right lower extremity.
This spontaneous report as received from a consumer (patient's spouse) refers to a 58 year old female patient. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency, route, lot#, expiry date unspecified) and was told that she did not have to worry about getting shingles. No concomitant medications were reported. On an unspecified date in May 2014 (reported as around two weeks ago), the patient broke out with shingles on her back, on the back sides on her hands, and her stomach. The rash also went around to her face. Reporter said that his wife had to be rushed to Hospital Emergency Room. The patient's physician diagnosed the rash as shingles. No laboratory test were provided. The outcome of event was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On an unknown dates, the unspecified patients were vaccinated with dose of ZOSTAVAX (Dose, route, lot # and expiration date were not reported). It was stated that the patients experienced shingles subsequently to vaccination. At the time of reporting, the outcome of herpes zoster was unknown. The causality assessment between herpes zoster and ZOSTAVAX was unknown. No product quality complain was involved. Additional information is not expected because the physician cannot be contacted.
pt recv vax & approx 1 wk post vax pt exp itching, redness & rash on neck, chest, & back;
Pt. experienced tremors, heart racing, increase in urination, weakness and light-headedness. Pt received 1 hot of Epi pen and patient went to E. R. where they received Benadryl and Prednisone 20 mg two daily for 5 days.
Patient had a mild fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient had a mild fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040X21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (Patient had a mild fever). At the time of the report, PYREXIA (Patient had a mild fever) had resolved.            No concomitant drug reported.  The patient had a mild fever and stayed home after 1st dose and had a fever and stayed in bed all day after 2nd dose.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-609311 (Patient Link).
Breakthrough case admission after three doses. Moderna 2/6/21 Lot# 013M20A; Moderna 3/6/21 Lot# 030A21A;  Moderna 5/13/22 Lot# 057M21A
Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing to eat, and developed a fever. Patient brought baby to local ER where assessments were performed, blood analysis revealed elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother's vaccination the previous day.
PT ARRIVED VIA POV WITH WIFE DUE TO COMPLAINING OF HAVING JOHNSON AND JOHNSON VACCINE REACTION THAT HE RECEIVED YESTERDAY AT 1130 AM. PT VOICED HE WAS NOT ABLE TO SLEEP MUCH, HAD FEVER, CHILLS; WOKE UP WITH SWOLLEN UPPER LIP, RASH OVER HIS UPPER EXTREMITIES; RASH AND WHELPS SEEN TO HIS RIGHT RIB REGION-MODERATE AMOUNTS. PT ALSO VOICED, FEELING ITCHING ALL OVER HIS BODY. DENIED OTHER SYMPTOMS. PT IS STABLE. ER PROVIDER NOTIFIED. TX: FAMOTIDINE, BENADRYL, SOLU-MEDROL, DECADRON.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age and gender. The patient's concurrent condition included allergy to aspirin (manufacturer unknown). The patient's concomitant medication was stated as "the patients takes "a long list of medications" but did not have time to provide the list". On 31-OCT-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously, lot # M017095 and expiration date: 28-JUN-2017 (dose number was not provided). On 02-NOV-2016, the patient called the pharmacy and reported that he developed "redness, swelling and tenderness" at the injection site. The events have not subsided at the time of reporting and the patient have to received any treatment for them. The reporter did not assessed causality between the events and the use of ZOSTAVAX. There was any product quality complaint (PQC) involved. This is one of 2 reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a 82 year old female consumer refers to herself. Patient medical history and current condition was not reported. On 16-FEB-2015 the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot number and expiry date not provided). Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced injection site swelling, weakness, tiredness and also reported that she had been sleeping a lot after receiving PNEUMOVAX 23. The patient reported that, she did not have any adverse effects after receiving the first dose of PNEUMOVAX 23. Product quality complaint was not reported. The outcome of the events was unknown. Additional information has been requested.
Hurt quite a bit; Upper arm was swollen and red; Upper arm was swollen and red; Got kind of lumpy and hurt quite a bit for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt quite a bit), PERIPHERAL SWELLING (Upper arm was swollen and red), ERYTHEMA (Upper arm was swollen and red) and SWELLING (Got kind of lumpy and hurt quite a bit for about 4 days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included BISOPROLOL, VERAPAMIL, CANDESARTAN, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE (SPIRIVA) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Hurt quite a bit), PERIPHERAL SWELLING (Upper arm was swollen and red), ERYTHEMA (Upper arm was swollen and red) and SWELLING (Got kind of lumpy and hurt quite a bit for about 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Hurt quite a bit), PERIPHERAL SWELLING (Upper arm was swollen and red), ERYTHEMA (Upper arm was swollen and red) and SWELLING (Got kind of lumpy and hurt quite a bit for about 4 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took second dose on 24-FEB-2021.   This case was linked to MOD-2021-040508 (Patient Link).
22OCT93 130AM t103.4, vomiting; mom gave APAP; 630AM resp ceased-no palpable pulse-parents gave CPR & rushed pt to ER; adm for observation; temp elevated 630PM 22OCT93;
I WAS TO BE ADMINISTERED TB TEST & WAS GIVEN TDAP VACCINE INSTEAD, SUBCUTANEOUSLY IN MY FOREARM.
Exactly two weeks after the first dose, I developed severe vaginal  hemorrhages/blood clots during the first day of my menstrual cycle. I have known history of blood clots. I had approximately  twenty (20) within 10 hours, all the size four (4) inches or greater in diameter.
Screaming, inconsolable crying, screaming, blank stare, not making eye contact, very bad rash at insertion site and entire thigh
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 9 year old patient who on 19MAY1995 was vaccinated with a dose of varicella virus vaccine live. On 27MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.