chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days later (the fifth day after the second shot), I had my first ever outbreak of shingles. The shingles occurred on the right side of my face and over my right eye; Fever blister breakout on upper lip for the first time in several years began three days after second shot; This all occurred after the second shot: chest tightness; Extreme difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/ batch number: unknown) via unspecified route of administration in Arm Left on 05May2021 12:00 PM (age at vaccination was 23 years) as dose 2, single for COVID-19 immunization. The patient's medical history included bipolar 1, anxiety and eating disorder. The patient has known allergy for codeine. Concomitant medication was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/ batch number: unknown) via unspecified route of administration on in Left arm 14Apr2021 04:00 PM (age at vaccination was 23 years and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No other vaccine in two weeks. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. This all occurred after the second shot: on 06May2021, 01:00 PM, chest tightness and extreme difficulty breathing, which began within 24 hours of the shot then lasted another 24 hours. Fever blister breakout on upper lip for the first time in several years began three days after the second shot. Two days later (the fifth day after the second shot), she had her first ever outbreak of shingles. The shingles occurred on the right side of face and over her right eye. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with valacyclovir pills, steroid injection and pills for the events. The outcome of the events was recovering.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
Td given on 06/16/04-pt stated that she felt achy that evening, some Left facial swelling, Left arm edematous and erythematous. Swelling and redness has improved. Slightly fatigued. No treatment except for Advil for aches.
Pt vaccinated with MMR developed large welts 1/2 to 1 cm all over body painful swollen joints - extensive. Low grade fever. Rx Epinephrine , Hydrocortisone cream, Dyx Modrol IM, Atarax PRN itching.
Patient experienced low body temp, achy & stiff joint, abdominal cramps and diarrhea. These symptoms occurred with both doses of Hepatitis B vaccine. Lasted 2-3 days & resolved. Worse with first dose vs 2nd dosage. Resolved on its own.
Sore, Joints ache, Stiff, Stiff neck, Fever of 99-100 at evening, dizzy, eyes feel gummy, blurry vision, headache.
methicillin-resistant Staphylococcus aureus (MRSA)/itching, erythema in all extremities; right upper extremity cellulitis/continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 02-FEB-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered itching, erythema in all extremities with continued worsening swelling and erythema of the right upper extremity cubital fossa and a reaction with superimposed bacterial upper extremity infection. The pt was diagnosed with right upper extremity cellulitis and methicillin-resistant Staphylococcus aureus (MRSA). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of Staphylococcal infection and cellulitis were considered to be disabling. Upon internal review, the events of Staphylococcal infection and cellulitis were determined to be medically significant.
Information has been received from a registered pharmacist concerning a patient who was vaccinated with single dose of ZOSTAVAX about 6 months ago, and then within two weeks of receiving ZOSTAVAX the patient had chickenpox like rash and it was itchy. At the time of reporting, the patient outcome was unspecified. No further information is available.
Stomach pain; Lightheadedness; Back of calf swollen; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Back of calf swollen) and NAUSEA (Nausea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Back of calf swollen) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Lightheadedness) and NAUSEA (Nausea) outcome was unknown and PERIPHERAL SWELLING (Back of calf swollen) had not resolved. Not Provided          No concomitant medications were reported. The patient's daughter reported that three days after administration of the vaccine her father started to experience stomach pain, lightheadedness, and the back of his calf got swollen. Her dad went to the emergency room on 02-May-2021. He was given medications for nausea.   This case was linked to US-MODERNATX, INC.-MOD-2021-101833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101833:Case for daughter
103.8 temperature, severe headache, body aches, nausea, fatigue.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. From 24-MAR-2017 to 06-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M042497, expiration date: 17-MAR-2019 for prophylaxis. The patients experienced no adverse effects. Administered doses of vaccines experienced the temperature excursion of -14 to -10 degrees Celsius for 7 hours 30 minutes.  Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012312:
Very severe left arm pain, throbbing along entire course of humerus bone and down ulna/radius into wrist.  Pain was so severe  my blood pressure shot up very high, I couldn't stop hyperventilating, and my husband had to take me to the emergency room. They gave me dilaudid and a prescription for Percocet.  An X-ray was taken which showed only pre-existing arthritis of shoulder joint.  My doctor told me this was very characteristic of "Covid Arm" others had experienced with the Moderna vaccine.
Client reports while driving home from the HD she had heart palpitations and dizziness that lasted several minutes. She then reported she continued to have heart palpitations and dizziness every time she ate any food over the next 48 hours. She also reported she currently has swollen lips and hives on her back, but she is allergic to chocolate and she ate chocolate yesterday evening. Client stated she has not seen a physician for her symptoms and when advised to follow up with her physician she refused, stating she knows her body and she no longer has any symptoms.
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 24-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that the temperature excursion duration was approximately 7 hours. The vial had reached the max temperature of 64 degree F.  It was reported that the vial was stored in refrigerator at the time of excursion. After administration the vial was returned to refrigerator. The date vial was moved from freezer to refrigerator was unknown. It was reported that the vaccine did not presented any state change on visual inspection. It was unknown the number of vials/doses impacted. Pertinent details of the vial was reported as unpunctured.  It was reported that patient did not experienced any adverse events. Treatment medications were not reported.
This spontaneous report as received from a medical assistant refers to a 17 month old patient of unknown gender. On 11-NOV-2014, the patient was vaccinated with a 0.5 ml dose of PROQUAD (Merck), subcutaneous (lot # and expiration date were not provided). Other suspect vaccine also administered on 11-NOV-2014 included a 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided). On 11-NOV-2014, the patient received PROQUAD (Merck) and inadvertently received VARIVAX (Merck) at the same office visit. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Pt was on 15 min observation following injection. After approximately 10 min pt began to complain of feeling like her heart was racing, dry mouth and feeling "Jittery", dizzy and weak
Chest tightness start at 1:00pm, difficulty breathing 1:30pm, sore throat, restricted breathing/airways 1:45pm, dizziness and weakness throughout.
Headache, Arthralgia, Fever, NauseaVomiting, chills, fatigue, Narrative:
fever 103.7 2hr p/vax w/swelling to rt leg;seen by PMD 31OCT97 (5 days later) & told this was a rxn to shot;seen in ER 1NOV97 & told rxn to shot;seen by another PMD 9NOV97 swelling dropped to knee cap;adm to hosp;
Pt was possibly inadvertently given 1cc of Moderna vaccine instead of 0.5cc. Patient was notified. State of MD was notified.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. There pertinent medical history or drug reactions or allergies were none. On an unknown date in 2010 (reported as 3 years ago) the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported). Concomitant medications were none. On an unknown date in September 2013 (reported as 2 weeks ago), the patient had shingles on the forehead and right eye. The right eye was red. VALTREX was rendered as a treatment. No lab tests were performed. The outcome of the event was reported as recovering. The patient sought medical attention. Additional information has been requested.
This information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. Between 10-MAY-2017 and 16-MAY-2017, the unspecified patients were vaccinated with improperly stored doses of PROQUAD with lot number M009746 and expiration date on 23-AUG-2017. On 16-MAY-2017, certainly one dose of PROQUAD with lot number L051099 and expiration date on 17-JUN-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 90 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA014919: US-009507513-1705USA008472.
02/22/2021 1200 patient developed a pruitic, diffuse, papular rash. 02/22/2021 2100 patient with diffuse pain, papular rash now developing hives and peri oral edema and  is in terrible pain.
Patient returned to pharmacy on 9/13/11 complaining of numbness/tingling in left arm as well as inability to lift above shoulder. Told to take ibuprofen on scheduled basis for a few days. Returned 9/19/11 still complaining of symptoms. Told to visit MD. MD prescribed prednisone 9/27/11 and told patient that meds caused tendonitis & nerve pain.
Acute/progressive worsening of weakness resulting in flaccid paralysis (pt. unable to transfer d/t weakness in all extremities).   Neuro surgical intervention required.
chest pain, sweats, nausea, diaphoretci, tachypnea, possible V2 and V3 ST elevation,  pancreatitis,  gastroduodenitis, elevated lipase,  leukocytosis, hyperlipidemia,  myoclonus/twitching of face muscles
Information has been received from a physician concerning a female (age unreported) with a history of being overly anxious who was vaccinated with her first dose of GARDASIL (Lot# date, dose and route unspecified).  Concomitant therapy included ADACEL.  A little while after receiving her vaccination with GARDASIL she returned to the physicians office with an increased heart rate that subsided that afternoon.  No product quality complaint was involved.  Additional information has been requested.
sore arm for a couple days; aches for 24 hours, mostly in torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 11:30 (Lot number: ER2613) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE, administration date 08Mar2021; OMEPRAZOLE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm for a couple days"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches for 24 hours, mostly in torso".  Additional information: The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19. Patient had no allergies to medications, food, or other products. Location of injection information was available for other vaccines within 4 weeks prior. No follow-up attempts are possible. No further information is expected.
Received vaccines and then became pale and sleepy. Referred to hospital but then returned to baseline labs and X-ray done the following day.
Patient complains of tenderness and swelling at injection site and an emerging sore throat that seemed coincidental to IMZ administration. Patient has bruise at IMZ site.
Soreness swelling and bruising at injection site, fever of 103 and chills treated with ice packs, Anaprox, and bed rest.
My whole body started shaking an hour later as soon as I got home. Heart started to race. Went away but came back every two hours during the night. The following week went into doctors office and they took some blood work and also sent me home with a heart monitor. Seeing that it was only happening at night or early morning. Couldn't get to doctors office quick enough to show them the shakes. Weeks later got better and not as frequent at night. Now It only wakes me in the morning with the shakes or trembling trembling hands. So hard to describe.
No known adverse effects.; a patient received a dose of M-M-R II (lot: N032748; expiration: 11/20/2019) that was prepared using an expired diluent (lot: M040792; expiration: 05/29/2019).; Information has been received from a pharmacist referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 01-JUN-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N032748, expiration date: 20-NOV-2019, therapy type: rHA, dose, frequency were not reported) subcutaneously that was prepared using an expired sterile diluent (lot #: M040792, expiration date: 29-MAY-2019, strength, dose, frequency were not reported) (expired product administered). No known adverse effects.
This spontaneous report as received from a registered nurse refers to a 14 years old male patient. The patient's pertinent medical history included asthma. The patient had unspecified allergy reaction to penicillin and had no concomitant medications. On 19-AUG-2016, the patient was vaccinated with the first dose of M-M-R II injection, albumin status of recombinant human albumin (rHA), 0.5 ml, subcutaneously in the right arm, lot # M002418, expiry date 12-JAN-2018 and the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, 0.5 ml, intramuscularly in the same right arm, lot # U5315AA, expiry date 29-APR-2018 for initial vaccination. On an unknown date in August 2016 (reported as "sometime afterwards"), the patient experienced bad reaction and sought medical attention in the emergency room at the hospital on 22-AUG-2016. The nurse described the bad reaction as "the right shoulder, more than halfway down the arm, was red, swollen, lumpy, painful, and swelling up towards neck and the neck was stiff". The nurse reported that, the physician prescribed treatment with prednisone (manufacturer unknown), albuterol breathing treatment, BENADRYL and epinephrine. The patient had lab diagnostic studies performed which included a complete metabolic panel and a complete blood count. The results showed elevated monocytes and eosinophils and also the lymphocytes were low. The patient was not admitted to the hospital and was sent home. At the time of this report, the patient was still recovering and was not in distress. The reporter did not provide the causality assessment between the events and M-M-R II and other suspect vaccine. Additional information has been requested.
Patient was in for routine office visit on 2/22/2010. Patient was offered and accepted the H1N1 vaccine. After paperwork was filled out and signed by patient, the vaccine was administered in left deltoid. Patient tolerated the procedure well with no complaints. Patient called at approx 4pm, patient stated that he was experiencing left wrist to hand discomfort/pain with tingling into left pinky finger. Patient denied SOB, radiating pain or chest pain. Doctor was notified, advised patient come in now to be seen. Patient stated that he went to work after his appointment, had driven a truck and was on his way back to area. Doctor was notified, advised the ED or urgent care. Patient went to urgent care, diagnosed with peripheral nerve entrapment/paraesthesias. MOTRIN IB 3 tabs every 8 hours x 3 days prn was recommended. Patient called on 2/23, stated better today. Declined a follow up visit offered. Writer called patient 2/24 to see how doing. Patient stated slowly getting better, c/o intermittent tingling today. Declined follow up appointment offered.
Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some; Felt a little Warm at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L208) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm pain since 3/19/18 after getting a Tdap. Pain is worse in the morning. She had significant pain when she raises her arms to put her hair in a ponytail. The pain is bad enough that she does not continue to put her hair up. She had no redness or swelling in the area. She has not had problems with a vaccine in the past. She had no pain in the shoulder prior to the shot. The pain she feels is deep. She had no other trauma to the area. No previous shoulder problems. She has tried heat and ADVIL without success.