chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Jul2021 at 10:30 as dose 2, single (Lot number: EWD153), in left arm, on 31Dec2021 at 10:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE  (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient received PAXLOVID for COVID-19 treatment from 03Aug2022 to 07Aug2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound approximately 5 days after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm at injection site swelled up to the size of an egg and was still swollen at 10 days later
Fatigue 8:30 pm, 2:30 am upset stomach, slight head ache, (unable to go back to sleep) 9:00 am extreme fatigue  rash around the injection site (not sure when) Approximately 3pm (following day10th) upset stomach and head ache stopped.  Fatigue diminished.  Fatigue gone 6am on the 11th. Rash still visible and minor itch.
congestion, sore throat, mild h/a, nasal & bronchial secretions yellow;sick 24hrs p/vax;seen office 28SEP temp inc but cough persisted 1wk; resolution thereafter
Patient presented to hospital ER the evening she received vaccines. Patient had 3 seizures witnessed by her mother. The seizures started around 10:00 pm and lasted about 1 minute in duration. Mom reported that patient had fever before seizures. Patient was given IV KEPPRA and admitted to the hospital for further evaluation. Patient was discharged on 4/29/15.
Shortly after receiving Rotavirus orally, after a few drops child vomited, cried & became startled - attempted again in upright position in my arm when mother noticed left leg appeared purple lasting approx 1 minute.
The pt experienced a left arm that was swollen from the site of injection to the elbow. The pt also experienced redness, warmth to the touch, and chills that evening. Some nausea was also experienced.
A report has been received from a Health Professional concerning an 8 year old, Male subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Dec-2013. The medical assistant reported that on 20-Dec-2013, two patients received expired FLUMIST QUADRIVALENT. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious by reporter.
No adverse reaction noted per patient's father. Pediarix given about 13 days apart. So, patient received an addtional dose.
Patient states a painful rash developed in the  eft axilla accompanied by a single hard  nodule about the size of a quarter 24 hrs post vaccination.  I saw the patient  on day two. Noted  multiple flat erythemic  rash at  the left   axillary pocket there is no palpable nodule but site is tender to touch. There is also a single flat discrete erythemic   plaque located along the mid axillary line, right next to the  serratus muscle.  Vital sign is stable, member is afebrile, ROM is not affected. Member advised to take Tylenol for treatment of pain
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX in 2014, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as shingles with acute neuritis. Patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Left upper arm pain immediately after injection. Still having pain over four months later. Very upset. Saw me (her primary MD) today for evaluation. Referred for physical therapy.
After patient was admitted vaccine, he was noted to have clammy skin,  Pt was aware and he complain of feeling cold, Epipen administered to him on rt and left thigh. VS was unable to register at first. Skilled nurse put him on 02 via n/c, after few mins 02 was 141/73, 103, 02 sat 99% with 02 in n/c. Blood sugar 105.
Pain in left arm radiating down to left hand, muscle cramps and soreness. Loss of strength.  All problems is to this date.
The day after vaccines parents noted that patient kept falling and losing his balance. (Had been walking well before). Would stand up and fall down. Last about 5 days. Today, the 6th day, report he is more steady but not completely back to normal. No fever. No vomiting. No nystagmus. No fussiness. Happy mood. Eating well.
Muscle spasms when trying to sleep. Legs and arms twitching. Occured throughout the night. Did not reoccur in the day. Started up again the next night.
Approx 2 hr p/vax pt devel fever 101.3. Also redness & firmness @inj site.
When pharmacist went out to check on patient 15 min post vaccination, patient reported she was not feeling great.  She reported an itchy throat-similar to when she eats shrimp, feeling really warm, and like her feet were not attached to her body.  Pharmacist gave 25mg of Benadryl, a glass of ice water, and an ice pack.  Pharmacist then called over a nurse to check her over in clinic.  As of time of this report (6:13pm) patient's vitals were stable.
C/o muscle aches pain to both legs on 2/12/21. Medicated with Motrin 200mg PO x1 dose. Still c/o of achiness but has improved. 2/13/21 C/o general muscle pain up to ears. Medicated with Motrin 200mg PO x1 dose, so far today.
Information has been received from two Licensed Practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, GARDASIL was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored GARDASIL, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Left thigh area reddened, swollen, and warm to the touch. Mom noticed swelling and circled with a pen by the time came to clinic next day redness was outside of the circle she had drawn. Mom did not apply ice or anything stating she did not know what to do and did not want to irritate it further.
Extreme chills, aches, fever, blurry vision, sweats then exhaustion. Those occurred until approximately 2am. Then night sweats, tired and achy. Today feel better but still night sweats altho not as bad.
Diagnosis of shingles was made 12-20-12 at Medical Center ER.
Vaccine given out of indicated age range. Patient was kept for 10 minutes after vaccine given. No issues or problems after vaccine given, patient stated that she felt fine
Patient was given 0.2 ml Pfizer (12+ dose), diluted with 1.3ml diluent.  No adverse events that occurred after vaccine to our knowledge during 15 minute observation time.
The patient received his 1st dose of the Pfeizer COVID shot in February or March. He then received the 2nd dose about 3 weeks later. The patient received his booster vaccine 11/4/2021. During the later part of December the patient became ill. It was thought he might have COVID, but he had not gone anywhere and did not have symptoms of COVID. It was thought the patient had an upper respiratory infection. The patient did recover after about 6 weeks. He then felt ill again and was having a hard time walking. He went to the hospital and was discharged after 4 days. The hospital advised the patient he had arthritis. The patient did not believe it was arthritis due to the fact that his symptoms appeared suddenly. The patient then went back to the hospital a couple of days later on 2/26/22. He then saw a neurologist. The neurologist diagnosed the patient with Guillain-Barré syndrome. The patient was just released from the hospital yesterday, 3/24/22, to a rehab center. The patient is now walking with a cane and walker.
Chills, temperature,  nausea/vomiting, temperature 100.5, body ache, arm redness/itching.
Low fever (100°F), headache, body aches, unusually tired, lack of concentration. This lasted for less than a day. I took ibuprofen, which helped.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
devel fever of 105 rectally w/rash, 7 days p/MMR;  t103.8, convuls, rash, ear infection;
Information has been received from a certified medical assistant concerning a 78 year old female with drug hypersensitivity to aspirin who on 15-JUN-2006 was vaccinated intramuscularly in the deltoid with 0.5 ml of Pneumovax 23 (lot # 651321/1036P) (no previous history of any injection with Pneumovax 23. Concomitant therapy included desloratadine (CLARINEX), HCTZ/triamterene (DYAZIDE), alendronate sodium (MSD) and fluticasone propionate (FLONASE). It was reported that at the time of vaccination, the patient had "no problems". The medical assistant stated that the injection was one of the last two doses administered from this lot. Subsequently, on 15-JUN-2006 the patient experienced excruciating pain in the arm without redness or swelling and stated that she "could not lift her arm". Unspecified medical attention was sought. The patient was told to take anti-inflammatory medications to help resolve the symptoms. The patient was to be followed by his physician. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
ACUTE DVT OF BILAT THIGHS, UNSPECIFIED VEINS 3/17/2023 &  2/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
epigastric pain, nausea, clammy, chills  Hospitalized inpatient Hospital
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M046004 with expiration date of 18-NOV-2018 or lot # M028547 with expiration date of 07-JUN-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion of the VARIVAX was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179:
feels weak; feels horrible; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), PREDNISONE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible). At the time of the report, ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
rash; tingling in my lips; she felt a flushing feeling; Arm Severely Very Sore at Injection Site; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in arm left on 04Mar2021 11:30 (age at vaccination 47 year) as single dose for COVID-19 immunization and received niacin (lot number: 004114 and expiration date: Apr2022) via an unspecified route of administration from 03Mar2021 to 06Mar2021, at 500 mg and via an unspecified route of administration from 07Mar2021 (lot Number: 004114; Expiration Date: Apr2022) to 08Mar2021, at 500 mg for cholesterol in pharmacy. Medical history included heart arrhythmia and cholesterol. Concomitant medication included heart medications. The patient previously took fenofibrate and experienced itch. On 04Mar2021, the patient experienced arm severely very sore at injection site. On 04Mar2021, the patient had first dose of the Pfizer COVID vaccine and she experienced a rash yesterday in the hip area, lower stomach, near the bra area, between shoulder and armpit, upper thigh, groin, tingling in her lips, and in other places on her skin on 09Mar2021. On 06Mar2021, the patient experienced flushing feeling, skin was on fire, skin and face were red, very unpleasant, all the way down to groin from the face and chest but nothing below her feet. The seriousness of the events was unspecified. On 06Mar2021, the event she felt a flushing feeling and arm severely very sore at injection site resolved. The outcome of the event rash and tingling in my lips was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 07-AUG-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2016, the patient was treated by her physician for a painful rash that was diagnosed as shingles with herpes zoster ophthalmicus. The patient was prescribed valacyclovir (VALTREX) for management of her symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Upon internal review herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Chills/tremors, aches, soreness at injection site, skipped/irregular heart beats
One day after Varicella placement, client developed 3-4 chicken pox at injection site. By day 4, client had chicken pox covering multiple body surfaces. On 6/19/18, 3 months later, client develops shingles in the same leg that Varicella was placed. Treated by dermatology with anti-virals. Referred to Infectious Disease.
About 1 week after receiving the vaccine I noticed my right arm itching, it took me a while to realize why. Once I looked at my arm in a mirror I saw that it was swollen, red & itchy. At the time the redness was about the side of a 1/2 dollar. The last few days I have noticed that my arm is itchy, red, swollen & now feels like a rash in the same location but the redness is about the size of a baseball.
back. pain; not being able to lay on the left arm due to pain in arm; chest pain; injection site reaction of redness to the left arm; Initial information was received on 26-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-HCP.  This case involves an 84 year old female patient who experienced pain in arm (pain in extremity), chest pain (chest pain), back pain (back pain) and injection site reaction of redness to the left arm (vaccination site pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, past medical treatments, vaccinations and family history were not provided. It was reported that patient is having macular eye issue and having a hard time with reading.   On 16-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via intramuscular route in the left arm.  On an unknown date, the patient developed non-serious pain in arm (pain in extremity), chest pain (chest pain), back pain (back pain) and injection site reaction of redness to the left arm (vaccination site erythema) (unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not reported.  Final diagnosis was pain in extremity, chest pain, back pain and vaccination site pain.   The patient did not receive any corrective treatment.  The events were ongoing at the time of this report.  Information on the batch number was requested.
Rash; Chills; Swelling of ankles, feet and legs; Swelling of ankles, feet and legs; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Jan2022 at 16:00 (Lot number: FF2855) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Acid reflux (esophageal)" (unspecified if ongoing), notes: reflux and "Allergy" (unspecified if ongoing), notes: Known allergies: yes. Concomitant medications included unspecified prescribed medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW6207, Anatomical Location: Left arm, Administration Time: 16:00), administration date: 21Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0150, Anatomical Location: Left arm, Administration Time: 16:00), administration date: 09Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: RASH (non-serious) with onset an unknown date in 2022, outcome "recovering", described as "Rash"; CHILLS (non-serious) with onset an unknown date in 2022, outcome "recovering", described as "Chills"; JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset an unknown date in 2022, outcome "recovering", and all described as "Swelling of ankles, feet and legs". The events "Rash", "Chills" and "Swelling of ankles, feet and legs" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of rash, chills, joint swelling and peripheral swelling.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Patient has extreme prematurity 25 wks. Has Hx of Apnea, Tracheomalacia, GER, Breath-holding spell. Infant died on the same day vaccines were administered. Infant died in her sleep.
Sudden rapid heart palpitations. Subsided after 2 minutes and drinking water. Did not return.
Patient received 2nd dose of vaccine too early. First dose was administered on 7/14/2021. No adverse reactions to vaccine noted. Patient to receive repeat dose of vaccine at 6 month interval of invalid dose.
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy  and sharp pain pain in eyes hoarse throat
SHINGLES ON BACK; NERVE PAIN / LEFT SIDE NERVE PAIN IN CHEST; CHEST PAIN; SPIKING SUGAR FROM 300 TO 400; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced spiking sugar from 300 to 400. On JUN-2021, the subject experienced chest pain. Laboratory data included: Sugar blood level increased (NR: not provided) Almost 400 than previous 300 (units were not reported). On 16-JUN-2021, the subject experienced shingles on back. On 16-JUN-2021, the subject experienced nerve pain / left side nerve pain in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on back, nerve pain / left side nerve pain in chest, chest pain, and spiking sugar from 300 to 400. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.