chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sores; Lips were swollen/Swelling lips; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips) in a 51-year-old male patient 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 ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips). The patient was treated with PREDNISONE for Swelling lips, at a dose of Unknown. At the time of the report, ORAL HERPES (Cold sores) and LIP SWELLING (Lips were swollen/Swelling lips) outcome was unknown.        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.   No concomitant medication was reported by reporter.  Prednisone shot was given by allergist.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow-up was received and contains no new information.
Patient received vaccine at 17:00 and felt fine.  She went to radiology for an x-ray and then pharmacy.  45-50 minutes after injection patient had uncontrollable shaking and chills.
Patient has received two doses of varicella. One at age 14 months of age and second dose at age 4 years old. He developed a case of chicken pox on 12/3/2018 with multiple lesions at the age of 8 years old. The disease was confirmed by the state lab.
Hemihypoaesthesia (numbness on the right side); Tired all the time; Early morning stiffness; This is a solicited report based on the information received by Pfizer from (Mfr. Control No. :21K-163-3813425-00). A contactable consumer (patient) reported that a 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 52-year-old, intramuscular on an unspecified date (Lot number and expiration date was not reported) as single dose for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Lot number and expiration date was not reported) to an unspecified date, at unspecified dose for Moderate to Severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced hemihypoaesthesia (numbness on the right side), tired all the time, and early morning stiffness on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of the events was not recovered.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: The causal relationship between BNT162B2 and the events hemianesthesia, fatigue and musculoskeletal stiffness cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The causal role of pre-existing RA cannot be excluded as well. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2015, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around August 2016, the patient was treated by a physician for herpes zoster or shingles and zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Hives 6 days after shot - still have hives 4 days later - will start Prednisone today after consult
ear infection; right ear had started to have fluid buildup; little bumps behind my ear; sneezing and watery eyes; left ear was inflamed and had fluid buildup; sinus pressure; pressure in my head; next day I was itchy; with certain foods, I seem to be having an allergic reaction; watery, itchy eyes; headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction) and EYE PRURITUS (watery, itchy eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (chemotherapy and radiation 10 years ago.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 30-Jan-2021, the patient experienced PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes) and HEAD DISCOMFORT (pressure in my head). On 02-Feb-2021, the patient experienced SNEEZING (sneezing and watery eyes). In February 2021, the patient experienced INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup) and PARANASAL SINUS DISCOMFORT (sinus pressure). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (little bumps behind my ear). On an unknown date, the patient experienced EAR INFECTION (ear infection) and FLUID RETENTION (right ear had started to have fluid buildup). At the time of the report, HEADACHE (headache), FATIGUE (little tired), PRURITUS (next day I was itchy), HYPERSENSITIVITY (with certain foods, I seem to be having an allergic reaction), EYE PRURITUS (watery, itchy eyes), SNEEZING (sneezing and watery eyes), HEAD DISCOMFORT (pressure in my head), EAR INFECTION (ear infection), INNER EAR INFLAMMATION (left ear was inflamed and had fluid buildup), FLUID RETENTION (right ear had started to have fluid buildup), PARANASAL SINUS DISCOMFORT (sinus pressure) and EAR DISCOMFORT (little bumps behind my ear) outcome was unknown.        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.   treated with Tylenol, Amoxicillin, Colloidal Silver
Immediately after administering vaccine, patient developed raised area at site of injection - advised to take Ibuprofen - when checked on pt next day, same symptoms.
On 1/30, 7 days following MMR, had several episodes of generalized seizures without fever and altered mental status lasting 24 hrs. Comprehensive tox screen negative. Normal EEG.
Covid vaccines always cause me to experience urology issues (UTI) Woke up at 1:30 AM with bladder pain; frequent urination every 2 hrs for the rest of the night Took D-Mannose in the morning, and thankfully bladder pain / frequent urination improved.  No further issues  With past Covid vaccines, had to see physician following vaccination(s)  for UTI diagnosis and receive antibiotics for treatment / recovery
It was discovered that after administration that the vaccine was expired. The vaccine was pulled from the fridge on 6/23/23 and is only valid for 30 days at refrigeration. Patient does not report any adverse events.
Patient is a 24-year-old female who is seen for evaluation of right arm injection site. Patient had hepatitis A injection in right arm on 10/3/18. Patient was given antibiotics about 2-3 weeks ago, but states she did not complete these antibiotics. Patient states the injection site became hard and erythematous at first, but progressed to current state of soft, fluctuant, and with dark/purple coloration of skin. Denies drainage. Reports itching. Denies fever, sweats, chills. States that the area overlying her right deltoid where injection site was placed is tender to touch. States that the lesion has not opened, but states it appears to have a pocket of fluid underneath the dark skin discoloration. Denies ever having a reaction like this before to an injection.  I and D performed.
Edema up to Shoulder of Left Arm with Blistering, Redness, "Fiery" feeling; Axilla. Blistering and Edematous - lasting 19 Days
Rapid pulse, sudden sever headache, high blood pressure.  Sent to the ER.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 12-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Pt noticed soreness and redness the day after he received the vaccinations. The redness extends around the circumference of the deltoid.
Saturday-headache, body felt like it was on fire, chills, aches and pains throughout, nausea, fatigue, site soreness, fever, restless. Sunday-headache, nausea, fatigue, brain fog Monday-tiredness, fatigue, confusion
he had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (he had a sore arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (he had a sore arm). On 09-Jan-2021, PAIN IN EXTREMITY (he had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-347110, MOD-2021-347111 (Patient Link).
mild pain at the injection site; mild pain at two locations on face; swelling at two locations on face; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 18:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included factor v Leiden. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), phentermine (MANUFACTURER UNKNOWN) and vitamins nos (VITAMINS) on an unknown date for unknown indication. The patient previously took hyaluronic acid (JUVEDERM), 4 syringes of JUVEDERM injections near both cheekbones and chin on 30 July 2020.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 18:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date Apr2021, 36 hours after vaccination the patient experienced two potential adverse events following the second dose of the COVID-19 vaccine. First, she experienced mild pain and swelling at two locations on her face. This occurred approximately 36-hours after her vaccination. Both are areas where she previously received facial fillers. She received 4 syringes of JUVEDERM injections near both cheekbones and her chin on 30 July 2020. The current pain/swelling was on her chin and right cheekbone close to those injection sites. It was now 12 hours after from the onset of facial pain/swelling and the issue persisted. The patient planned to follow-up with her physician the next day if the issue continued. Second, she also experienced mild pain at the injection site on her left arm. It began shortly after injection. She managed it successfully by taking the indicated dose of acetaminophen for 24 hours. The pain had largely gone. Therapeutic measures were taken as a result of the event and included treatment with acetaminophen for 24 hours.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild pain at two locations on face and swelling at two locations on face was not resolved. The clinical outcome of the event mild pain at the injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
weird side effect; She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a; she feels that her muscle is contracting/pulsating; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating). At the time of the report, ADVERSE EVENT (weird side effect), PAIN IN EXTREMITY (She has large metal plates in her left leg, and she feels that her muscle is contracting/pulsating a) and MUSCLE SPASMS (she feels that her muscle is contracting/pulsating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
left side sometimes still feels heavy; side of my face got tingly from eyes to cheek, still tingly; eyelids got heavy; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (left side sometimes still feels heavy), PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) and ASTHENOPIA (eyelids got heavy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included POTASSIUM, FUROSEMIDE, ATORVASTATIN, LEVOTHYROXINE and ESCITALOPRAM for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DISCOMFORT (left side sometimes still feels heavy), PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) and ASTHENOPIA (eyelids got heavy). At the time of the report, DISCOMFORT (left side sometimes still feels heavy) and PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) had not resolved and ASTHENOPIA (eyelids got heavy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
JE IXAIRO #2 Rabies RabAvert #3 administered 10 mins passed. Pt light headed, dizzy, heavy feeling across forehead, shaking.
BODY ACHE; SENSITIVE SKIN; HURT TO EVEN WASH HANDS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced sensitive skin. On 07-APR-2021, the subject experienced hurt to even wash hands. On 07-APR-2021, the subject experienced tiredness. On 08-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, hurt to even wash hands, and sensitive skin, and the outcome of tiredness was not reported. This report was non-serious.
Vaccine was injected into the shoulder joint causing extreme pain.  Band aid was directly over the joint.   I was not able to move the arm for 3 days.  Couldn't sleep or get dressed.  Pain gradually subsided but 6 weeks later I still have some residual stiffness.  Reported to Publix corporate office who did not take the information.  They had me call the store directly.  Evidently there is no corporate follow-up for problems.
fever 101.7 for around 24 hours, headache body aches, arm pain and swelling
12 hours post vaccine,  chills and fever, headache,  full body aches,  abdominal pain and nausea. Severe symptoms lasted 36 hours, same symptoms but less severe lasted 72 hours.  Now Friday, no fever or body aches, abdomen still sore.  But feeling better
High fever 102,5, extreme body ache, extreme headache, painful burning sore throat, extreme fatigue.
Patient received the vaccine on 1/16/20 in the afternoon.  The following morning he had a massive heart attack and had to be resuscitated multiple times.  He was sent to Hospital where he received two stents.  There we were informed that he also had multiple strokes and passed away on 1/26/20.
tingling feeling on different part of body, head , and feet; swollen all over body, knees, and elbows; red and itchy skin; red and itchy skin; feeling cold internally; hot externally; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin) and FEELING COLD (feeling cold internally) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Mar-2021, the patient experienced PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally). At the time of the report, PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally) had resolved. Not Provided          The patient reported that her reactions to the second vaccine were much like the first. The caller reported three separate episodes of these set of symptoms occurring on 01Mar2021, an unknown date, and again on 22Apr2021. After the onset of symptoms she stated that they lasted 1.5 hours.  No concomitant medication information provided. No treatment information was given. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-021416, MOD-2021-025546 (Patient Link).
Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report from a non-contactable Nurse(patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration at left arm on 12Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No COVID prior vaccination, no COVID tested post vaccination, no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), ethinylestradiol, norgestimate (SPRINTEC). No other vaccine received in four weeks.The patient experienced tenderness at site low grade fever on 13Jan2021 04:00. Facility type vaccine was hospital. No treatment received. Outcome was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
States approx 1 hour after flu shot her throat started feeling tight and sore. Voice decreased, could only whisper. Eyes very irritated, painful to touch and a drainage noted from her eyes.
Eight days after receiving the vaccine, I experienced itching at the site of the injection.  After getting out of the shower, I noticed a red rash at the site.  The itching lasted just 1 day and the rash lasted about 2.5 days.