chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning, stabbing sensation in toes and feet; numbness in several toes; Peripheral neuropathy of toes, feet, ankles and wrists; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Sulfonamide allergy (Reaction to sulfa). Concomitant products included GABAPENTIN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (Burning, stabbing sensation in toes and feet) and HYPOAESTHESIA (numbness in several toes). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy of toes, feet, ankles and wrists) had not resolved and BURNING SENSATION (Burning, stabbing sensation in toes and feet) and HYPOAESTHESIA (numbness in several toes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided  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.  However, more information is required for further assessment.; 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.  However, more information is required for further assessment.
pt c fevers on 2/3-2/5, presented on 2/6 with ataxia, resolving slowly, some left leg weakness and decreased patellar reflex
12hr post vax severe pain lt arm;inc pain over next 24hr + fever, chills;adm 2 days post vax t102.8;blood cult negative, placed on ATB, pred, DPH;
Hot/warm feeling in left arm/neck. Vitals wnl. Benadryl 50 mg PO given.
After receiving the vaccine I had arm soreness. Yesterday I went to my routine check up with my dentist. They found a lesion on my tongue. They told me to keep a watch on it. When they were getting ready to do my cleaning they saw that I had an infection on my gums in two spots on the left side of my mouth. They had to do a procedure on me to fill up my gums where the infection was. For 28 days I have to use a special rinse to swab my mouth  to help with the infection.
Swelling, pain, stiffness in almost all joints, knees, fingers, ankles, elbows.
pt recv vax & 2wk later devel Stevens-Johnson synd & mycoplasma pneumonia;pt hosp 23JAN97 & pneumonia was treated w/unspecified ATB;As of 28JAN98 pt remains in hosp;
35 yo F with NKDA presented to clinic for first Gardasil 9 vaccine.  Lot # W025977.  Injection was given in left deltoid at 1538 3/14/23.  Patient reported no history of passing out or feeling faint/lightheaded with injections or blood draws. Approximately 2 minutes later, the patient started to lose consciousness and was assisted to the floor.  The patient maintained a pulse but had pallor and irregular respirations with 100% O2 sat on RA.  HR 56 and BP 98/61.  The patient began to regain consciousness with 1 to 2 minutes.  Initially not orient to place or time but became more alert and oriented.  Was assisted into a wheelchair and then onto an exam table. Provider performed assessments.   1600: BP 97/66 mmHg, O2 sat 100% on RA, HR 71 bpm. 1620: BP 100/69, O2 sat 100% on RA, HR 83 bpm.  The patient complained of feeling warm and "motion sick." Ice packs, water, orange juice, and crackers provided for the patient.  Ondansetron 8 mg ODT was ordered for nausea but initially refused.  1700: BP 105/62, O2 sat 100% on RA, HR 76 bpm.  Ondansetron 8 mg given at 1703. Patient was advised this was a vasovagal syncopal reaction and she should not receive any additional HPV vaccinations.
prolonged pain at injection area; pain with lifting arm over head and certain other movements, has used Ibuprofen p.r.n.; no other treatment
red rash on face and red spotson both  palm , difficulty in breathing . increase heart rate. muscle pain in lower extremities, loss of appetite, fever , chills.
This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). varicella virus vaccine (non-gsk). On an unspecified date the subject received a dose of KINRIX (unknown details, unknown arm), and a dose of Varicella virus vaccine (Non-GSK) (unknown details, unknown arm). At an unspecified time after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced bruise injection site. The medical assistant stated the subject experienced "a local reaction to a KINRIX vaccination. Varicella was also received on the same arm, so it could be a reaction to both." The medical assistant described the local reaction as looking "like a bruise." The mother of the subject provided pictures to the physician's office. No additional information was provided. At the time of reporting the outcome of the event was unspecified. Follow up was received from the physician on 18 June 2013. The physician documented that the subject was a 4-year-old female and on 15 May 2013, at an unknown time after vaccination with KINRIX and Varicella virus vaccine (non-GSK), the subject experienced bruise at injection site (described as "medication side effect"). Per the physician, the KINRIX was administered to the left arm intramuscularly and the Varicella Virus Vaccine was administered to the left arm subcutaneously. The physician documented that the outcome of the event as resolved. The physician documented that the event was probably related to KINRIX. The physician documented that KINRIX was the suspect product; however, the physician did not alter or remove Varicella Vaccine as a suspect product for the event. The physician documented that the subject did not die, was not hospitalized, the event was not life threatening, involve severe or permanent disability or jeopardize the patient or require intervention, and did not involve a congenital anomaly or birth defect. The physician did not consider the event to be serious. The physician documented that he did not feel that the event was associated with medical history or concurrent illness, a lack of efficacy, erroneous administration and was not suspected transmission of an infectious agent via a medicinal product. The suspect drug was not reintroduced and the subject had not received the suspect product before.
On day 8 after the first dose of the Moderna Covid Vaccine a rash began to develop around the injection site.  The area was swollen and hot and the rash spread to about 5 inches in diameter.  After 5 days the redness, heat and swelling diminished.  It is now a week after the rash developed and the rash is diminished but not gone.  I am using Benadryl topical cream on the rash which seems to be helping.
developed extensive DVT of LLE and PE on approx 3/27 admitted to hospital on 3/29
pt exp nausea, fever, irritable, swelling in arm-lt arm;muscles are tight, numb muscle spasms, thirsty, tired, sleepy, dizzy, drowsy;
Awoke with Flu-like symptoms: nausea, vomitting, fatigue, muscle soreness
Pt recvd vax on 30NOV92 & on 1DEC92 opposite side from where the inject was given pt devel edema of the neck, subclavian venous occlusion & was hospitalized;
While sitting in the recovery area, patient's family noticed patient was not responding. Pt was placed onto the floor by nurse and turned onto his left side. Patient had noticeable clenching and jerking. After approx. 5 mins, patient was alert and oriented x3. Vital signs obtained. BP 130/88 HR 108 SpO2 98% room air. Patient sat upright on his own. Gatorade water given. Cold compresses applied to neck and head.  Vitals obtained again. BP 120/90 HR 91 SpO2 98% room air. Patient declined to have EMS called. Extended monitoring done. Patient ambulated from facility with mother and father. No acute signs of distress noted.
No additional AEs; an expired PNEUMOVAX 23 vaccine was administered to a patient; This spontaneous report has been received from a pharmacist referring to a patient of unknown gender and age. The patient's medical history, current condition, and concomitant therapy were not provided.   On 22-AUG-2022, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (formulation: formulation syringe, valid lot #T032003 with reported expiration date 08-MAY-2022) (strength, dose description, and route of administration were not provided) for prophylaxis (expired product administered). There was no additional adverse event reported (no adverse event).
pt recvd vax & devel a 4 by 4 cm raised area around the inject site; also had pain which limited ROM;
Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 25 year old female with allergy to Morphine who in approximately June was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot # not provided). On 02-SEP-2008 the patient received the second dose of GARDASIL vaccine (yeast) (lot # not provided) and soon afterward found out she was pregnant. Her LMP was approximately 07-AUG-2008. Expected date of delivery was 14-MAY-2009, The patient had no medical history. Concomitant therapy include Pindolol, vitamins (unspecified) and CELEXA (reportedly being discontinued). In early September 2008, the patient experienced stomach pain, abdominal pain, rib pain, nausea, dizziness and shakiness. Therapy with GARDASIL vaccine was discontinued. At the time of the report, the patient had not recovered from the adverse experiences. The patient did not seek medical attention. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL8982), in left arm and on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular); "Slight hypertension" (unspecified if ongoing), notes: Slight hypertension; "Slight cholesterol issue - all under control." (unspecified if ongoing), notes: Slight cholesterol issue - all under control.; "Known allergies: Penicillin (maybe - childhood response)" (unspecified if ongoing), notes: Known allergies: Penicillin (maybe - childhood response). Concomitant medication(s) included: PYRIDOSTIGMINE, start date: May2021; PREDNISONE, start date: May2021; LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Started with heart palpitations and shortness of breath the day or the vaccine 3/26/21 that got better, next day had more heart palpitations mild no concern on Tue 3/30 suddenly woke up at 5 am with heart palpitations that didn?t get better in 45 minutes felt chest pressure and dizziness, called 911 paramedics performed an ekg heart rater elevated but nothing of concerned no emergency room, felt odd with palpitations all day and night Tue, Wed, Thursday with suicidal thoughts  but attended to PCP appointment prescribed anti depression and anxiety pills (Trazodone 50 MG) and she sent me to the Cardiologist attended to Cardiologist on Fri mild symptoms of heart palpitations and prescribed (Metoprolol Tart 25 MG) Symptoms were bad until meds kicked in, symptoms are still here including insomnia which I have insomnia before but this is way much worse and I never had hart related problems or palpitations
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L048465, expiration date on 02-DEC-2016)(dose number, strength and anatomical location, were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. Previous temperature excursion was reported as: Exposed to 45F for 24 hours. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from same source.
Feels scared; Itching at the injection site; Fast heart beat; Black and blue from the injection; Bled a little during administration of the vaccine; It was slightly pink ath injection site; Lump in her arm at injection site; Hasn't slept well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine) and VACCINATION SITE SWELLING (Lump in her arm at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site) and VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site). In January 2021, the patient experienced INSOMNIA (Hasn't slept well). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and HEART RATE INCREASED (Fast heart beat). On an unknown date, the patient experienced FEAR (Feels scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) (topical) in January 2021 for Vaccination site pruritus, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site), VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site), INSOMNIA (Hasn't slept well) and FEAR (Feels scared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jan-2021, it was day 8 and lump size was a little bigger than a silver dollar.
Information has been received from a physician assistant, concerning an 18 year old female patient. The patient had no pertinent medical history and no known drug allergies or reactions. On 16-OCT-2008, 17-DEC-2008 and 12-APR-2009, the patient was vaccinated with the first, second and third dose of GARDASIL respectively, (doses, routes and frequencies were not reported) (Lot # and expiration dates were not reported). On 10-JAN-2013, the patient tested positive for Human papilloma virus (HPV) 16. The patient was referred to the OBGYN to seek medical attention. No treatment was given for the event. At the time of the report, the patient's outcome was unknown. The relatedness for tested positive for HPV16 was unknown for GARDASIL. Additional information has been requested.
Tinnitus after the second dose; This is a spontaneous report from a contactable consumer (reporting himself). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration in left arm on 29May2021 at 10:00 (age at the time of vaccination was 72-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient had no relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on 29Apr2021 at 09:00 as a single dose for COVID-19 immunization. On 02Jun2021, the patient experienced tinnitus after the second dose and resulted in disability or permanent damage. The patient did not receive any treatment medication for the event. The outcome of the event was not resolved.  Information on Lot/Batch number is available; Further information has been requested.
Approximately 25-30 minutes after vaccines administered, patient returned to clinic with both eyes almost swollen shut and difficulty breathing.
Severe psoriasis outbreak over the entire body roughly three weeks following the second dose of Pfizer vaccine.
sore arm after the vaccine on the injection site; This is a spontaneous report from Pfizer-via Regulatory Authority Support from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after the vaccine on the injection site on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.). At the time of the report, IMMUNISATION REACTION (he had Moderna and Pfizer vaccines and has learned information since that could jeopardize his and his wifes health.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient received the initial booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
About 18 months ago, I was bitten by swarms of black flies and had a strong reaction to numerous bites on both arms. Inflamed, itchy, painful. They went away after 2 months. Within a week of the second dose of the vaccine 02/26/2021, the exact pattern of bites showed up again on both arms. Very itchy, inflamed, and looking like bites again.  Could this possibly be related?
weakness; pain in the chest due hernia; migraine; Hernia; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHEST PAIN (pain in the chest due hernia), MIGRAINE (migraine), HERNIA (Hernia) and SOMNOLENCE (sleepiness) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), CHEST PAIN (pain in the chest due hernia), MIGRAINE (migraine), HERNIA (Hernia) and SOMNOLENCE (sleepiness). At the time of the report, ASTHENIA (weakness), CHEST PAIN (pain in the chest due hernia), MIGRAINE (migraine), HERNIA (Hernia) and SOMNOLENCE (sleepiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication s were reported. No Treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up information received and included updated event outcome and no consent for further follow-up.
Patient received booster dose of Moderna on 8/26/21. (Completed 2 doses of Pfizer in the beginning of the year). A couple of days later, patient c/o weakness, lethargy, N/V, body aches. His meal/fluid intake reduced. Blood labs ordered per providers which showed mild AKI and elevated CK. He was given IVF and follow up labs drawn which showed improvement in his renal function and CK. Currently back to his baseline and doing well.
About 7 hours after receiving the shot, I did feel quite sore in my left arm (where the shot was administered) About 21 hours after receiving the shot, I started feeling very "Fluish", meaning lethargic, feverish and achy but without registering an actual fever about 28 hours after receiving the shot, I felt the symptoms escalate and felt even worse and remained bed ridden until about 44 hours after receiving the shot (started feeling better at about 11am on 4/2/21)
(L) upper arm swelling/redness/tenderness - developed ~ 1 day after injection (Seen in office 2d after injection).Tx'd with Loratadine/cool packs. Likely reaction to Pneumovax (tolerated flu shots in past).
Shivering, feeling extremely cold, weak , pain in shoulder and neck, unstable on my feet Wrapped myself in an electric blanket and took a Tylenol?did not sleep at all that night. Took Tylenol again the next day - lots of fluids- minimal food- and rested all day. Shivering had ceased by morning. Still feeling weak after two days?
Patient presented to the ED and was subsequently hospitalized for pneumonia due to covid-19 virus within 6 weeks of receiving COVID vaccination.