chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling lips; tremors; dizziness; her throat was closing; voice seemed affected; her heart was racing; high blood pressure; swelling of her face; shortness of breath; hive on cheek; redness of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face) and PARAESTHESIA ORAL (tingling lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy (Patient stated that she had in the past an anaphylactic allergic reaction to shellfish). Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNEA (shortness of breath), SWELLING FACE (swelling of her face), URTICARIA (hive on cheek) and ERYTHEMA (redness of face). On 06-Mar-2021, the patient experienced PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing) and DYSPHONIA (voice seemed affected). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In March 2021, DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing), DYSPHONIA (voice seemed affected), URTICARIA (hive on cheek) and ERYTHEMA (redness of face) had resolved. Not Provided          No concomitant medications reported.  Treatment of the events included (125mg Met prednisolone 50mg Benadryl) IV 40mg Prednisone 2 tablets per day until March the 22nd Benadryl capsules every 6 hours until march the 11th.
PATIENT STATES SHE WAS SORE ON WEDNESDAY - ON FRIDAY BELOW VACCINATION SITE THERE WAS REDNESS, HOT TO TOUCH, "HIVE" AREA, ITCHY.  PATIENT HAS TAKEN BENADRYL. PATIENT STILL EXPERIENCING THESE SYMPTOMS AS OF 6/19/23.  UPON SPEAKING WITH PATIENT ON 6/19, I RECOMMENDED TO ICE AREA, CONTINUE ON BENADRYL AND TO FOLLOW UP WITH MD.
WITHIN 5 MINUTES AFTER ADMINISTERING VACCINES TO THE PATIENT, HE HAD HIVES AND REDNESS AROUND HIS FACE.  BENADRYL WAS ADMINISTERED AND HE WAS SEEN BY DR.  HE WAS WATCHED FOR THE NEXT HOUR AND SYMPTOMS RESOLVED.  SENT HOME.
They were very very weak; no strength to get up same incident as this [after first or second dose]; so weak that when he got up to go to another room, after 3 step, collapsed; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed). At the time of the report, MUSCULAR WEAKNESS (They were very very weak), ASTHENIA (no strength to get up same incident as this [after first or second dose]) and FALL (so weak that when he got up to go to another room, after 3 step, collapsed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. Patient had no strength to get himself up. This was 1 AM, so he had to call paramedics to help him up and get him to his bed. He thought this may have happened after the first or second shot; he was unsure of the date. He had the same incident as this.  This spontaneous case concerns a 75-year-old male patient with no relevant medical history who experienced non serious unexpected event of special interest (AESI) muscular weakness. The event occurred after the first or the second dose of the Moderna COVID-19 vaccine and reoccurred one day after the third, booster dose. Rechallenge was positive since the event reoccurred with the next dose.  The benefit-risk relationship of product is not affected by this report   This case was linked to MOD-2021-391921 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history who experienced non serious unexpected event of special interest (AESI) muscular weakness. The event occurred after the first or the second dose of the Moderna COVID-19 vaccine and reoccurred one day after the third, booster dose. Rechallenge was positive since the event reoccurred with the next dose.  The benefit-risk relationship of product is not affected by this report
Axillary Lymph Node Swelling and Pain (swollen area the size of a softball in my armpit). Fever, Chills, Sweating. Nausea. Fatigue.
patient was inadvertently administered with only one component of Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00598868) and transmitted to Sanofi on 12-May-2021.  This case involves a female patient with unknown demography who was inadvertently administered with only one component suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number and expiry date were not reported) via unknown route at an unknown administration site (product preparation issue) for prophylactic vaccination on an unknown date.  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  The reporter requested guidance on how to proceed.   It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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 the 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 on the batch number for this case.
Moderna COVID-19 Vaccine EUA The nurse injected the vaccine too high on my right arm and caused SIRVA. I photographed the injection site a week after the shot was given, and again about a month later. Both photos show the faint imprint of the Band-Aid that the nurse applied to my shoulder after giving me the shot, as proof that the shot was given too high on my arm. I removed the Band-Aid the evening of the day the shot was given and don?t understand why the Imprint should remain visible that long afterward. The pain of SIRVA remains to this day, but it is not as bad as it was in the first few weeks. It hurts only when I move the arm  In certain directions, and the pain is not very intense. I have not sought medical treatment for the SIRVA, but did try Advil, a heating pad and cold packs.  Nothing seemed to help. The pain just lessened over time.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 38-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 14 May 2011 the subject received a dose of BOOSTRIX (details unknown). On an unspecified date in 2011, less than one year after vaccination with BOOSTRIX, the subject experienced injection site redness (within 2 to 3 centimeters of the injection site), injection site pain and injection site pruritus. The subject was treated with Antibiotic cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported 3 subjects who experienced adverse events following BOOSTRIX administration. This is case 1 of 3; see cases A0933923A and A0933924A for details of the other reports.
Day after I had chills, body aches and fatigue.  I spent 15 hours in bed and woke up with lower back pain.  Within several hours I could walk due to severe pain.  I presented to the emergency department the following morning and have a herniated disc with tear and lumbar sprain/spasms.  I?m on day 3 of admission for pain management.   The disc and tear may not be new or vaccine related but this severe back pain i think could be.
I have been so dizzy; Also have diarrhea; Arms are a little sore; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have been so dizzy), DIARRHOEA (Also have diarrhea), PAIN IN EXTREMITY (Arms are a little sore), CHILLS (Chills) and NAUSEA (Nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E214) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer stage III. Concomitant products included LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced DIZZINESS (I have been so dizzy), DIARRHOEA (Also have diarrhea), PAIN IN EXTREMITY (Arms are a little sore), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, DIZZINESS (I have been so dizzy), DIARRHOEA (Also have diarrhea), PAIN IN EXTREMITY (Arms are a little sore), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up contain no new information
ON AND OFF SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced on and off shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on and off shortness of breath was not reported. This report was non-serious.
Starting 1 week after the initial dose she developed a diffuse itchy rash, the rash flared all over the body 3-4 days following the second dose. Evaluated in my office 9/21/21 at which time biopsy was performed as detailed below consistent with cutaneous lupus. Systemic workup negative for systemic lupus.
This spontaneous report as received from a physician refers to a 9 year old male patient. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 16-MAR-2018, the patient was inadvertently vaccinated with expired VAQTA (0.5 ml, intramuscular, lot # M033611, expiration date 02-MAR-2018) for prophylaxis. No adverse effects reported.
Headache, Arthralgia, Fatigue Narrative: missed work following 2nd dose due to symptoms
After lunch was sitting down and stood up and felt dizzy. Lost focus on vision on right eye. Right side of face was odd, not numb was at home with wife. For 3-4 hours felt really dizzy. Balance was off; wouldn't have been able to drive. Called doctor who told him to call if other symptoms occurred. Today feels fine. Right eye not as focused s left eye but it is improving. Run through the stroke symptoms checklist just in case but no symptoms meet criteria. On 6/3/15 symptoms lasted through suppertime.
Extreme uncontrollable chills for over an hour, followed by an entire night of high fever. Unable to sleep to due ill feeling.
He was also given the Janssen covid vaccine  on 3/31/21. He did not report this information when offered the moderna vaccine. No adverse symptoms have been reported.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in October 2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (lot #, dose and route were not provided) and then the patient was inadvertently administered a second dose of ZOSTAVAX 19400 Plaque-Forming Units (lot # M013377, expiration date: 25-MAY-2017; dose and route were not provided) on 12-SEP-2016. No adverse effect was reported. Additional information has been requested.
Temperature of 100.04, head ache, back ache, muscle ache  Running nose
Swollen red circles about 2 inches in circumference for one and a little smaller for the other. Rock hard where the injection was. The red circles got bigger and bigger and then as they faded were bruised purple. Extreme fatigue (may be normal but want to document). The circles were on her arm for about 4 days. Starting out small  then gradually getting bigger.
I was hospitalized because I was feeling really sick, I was dehydrated. I got iron, fluids, they switched my medication from STELARA to ENTYVIO, 35mg of prednisone. And since then, I have had 5 more iron infusions and multiple doses of ENTYVIO. And I had blood work a week ago and things are not improving. They up'd my iron and shorten my ENTYVIO from every 8 weeks to every 4 weeks. I have still fatigue, diarrhea, dehydration. I have unnormal kidney levels. A new doctor is my gastro doctor.
Pt recd vax in ER as result of having dirty needle stick-lt arm began to hurt shortly after; By next day was swollen, cellulitis, dizzy, vomiting; tx in ER w/Augmentin-recovered;
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored (7 Fahrenheit, cumulated time of 3 weeks) PROQUAD (lot # M010475, expiration date 01-SEP-2017). There were no temperature excursions previously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since we have no consent to contact the nurse.
This case was reported by a pharmacist and described the occurrence of subdural hematoma in a 6 month old female pt who received Pediarix. On 1/7/04, the pt received a dose of Pediarix (21913A9). On the same day, the pt received Act-Hib and Prevnar. Approximately eight days later, on 1/15/04, the pt experienced a subdural hematoma, a seizure due to encephalitis, a retinal hemorrhage, difficulty swallowing, inability to open eyes, and unresponsiveness. The pt was seen at an ER. A CAT scan confirmed the hemorrhage and encephalitis. The seizure, unresponsiveness, and inability to open eyes resolved. The subdural hematoma and the difficulty swallowing improved. The patient was placed on a feeding tube while hospitalized. As of 2/12/04, the retinal hemorrhage was unresolved. The pharmacist stated that shaken baby syndrome was suspected. At that time, the patient continued to experience visual problems.This case was assessed as medically serious (OMIC) by manufacture. Follow Up: The patient was discharged form the hospital on 18February 2004. At that time, the patient continued to experience visual problems. Retinal hemorrhage had resolved in one eye but continued in the other eye. The pt also experienced inflammation in the nonhemorrhaging eye. At the time of discharge the patient was able to consume formula with rice cereal, and her overall condition assessed as improved. The pharmacist reported that the patient's babysitter had been charged by the prosecuting attorney for shaken baby syndrome. The reporting pharmacist is the patient's aunt. At the time of reporting, diagnostic results including platelet count and coagulation factor were unavailable.  As per annual follow up report: April 27 2005 Aunt stated CT and MRI of brain showed brain damage spot. She stated the subject is now 2 years old and not talking only baby garble. Also she stated subject is still having difficulty swallowing.
erythema, induration, & warmth extending from the elbow to the shoulder;tender w/movement;tx w/Ibuprofen-dose uncertain because it was administered erratically;resolved in 7 days;
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
70 year old patient reported diarrhea and fatigue for three days following his second dose of COVID-19 Pfizer vaccine. No treatments used. Patient received first pfizer dose with no issues
Pain in shoulder, back, and arm despite mult. analgesics and interfering w/ ADL's; >1mo.
really nauseous; do not feel good; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (really nauseous) and MALAISE (do not feel good) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (really nauseous) and MALAISE (do not feel good). The patient was treated with ONDANSETRON at a dose of UNK dosage form. At the time of the report, NAUSEA (really nauseous) and MALAISE (do not feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
I?m the patient. I have had a horrendous memory. I has in the hospital. These questions I could typically answer but since being hospitalized ; even a few weeks / months prior me memory is horrendous.
States she had the shot in her upper left shoulder.; Lump by upper left back, shoulder blade; Lump by upper left back, shoulder blade; she sees injection site and arm pit pain; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient had the shot 2 weeks ago and going for the third one in September (details unspecified). The patient reaction was a lump and had the shot in her upper left shoulder. Afterwards, towards her upper left back, shoulder blade and had a lump. The caller asks if this was a side effect then the patient states that she did not saw it listed in the side effects and the patient saw injection site and arm pit pain but nothing like this lump the patient had. The outcome of the events was unknown.   No Follow-up attempts are possible. No information is expected further.
Patient had arm soreness for a few days following vaccine and mild redness for 1-2 days. On 1/4, she developed an area of redness at injection site, about 2.5", warm to touch. She did not have a fever or pain. She was referred to urgent care for evaluation as unable to be seen by primary care office that day.
Deviation from time-frame: second shot on the 42 day; A spontaneous report was received from a Reporter like HCP concerning a 53 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of vaccine administration.    The patient had an emergency dental procedure because root canal was not done properly. Concomitant medications included cymbalta 30 mg and bystolic 5 mg. The patient is on antibiotics and steroids.   On Date 31-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the Left arm for prophylaxis of COVID-19 infection and on 09-FEB-2021 patient received second of two planned doses in right arm (lot/ batch: Not provided).   On 9-FEB-2021, the patient experienced her second shot on the 42nd  day after the first vaccine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event "deviation from time-frame: second shot on the 42 day" was considered resolved on 09-FEB-2021.; Reporter's Comments: This case concerns 53 year old female patient who received second of two planned doses in right arm (lot/ batch: Not provided) 42 days after the first dose. No reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.