chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful; looks like Covid Arm, hot to touch, and painful; Injection site is a bright red mark; had terrible Chills; Fever went 103 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful), CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 27-Mar-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 27-Mar-2021, the patient experienced CHILLS (had terrible Chills) and PYREXIA (Fever went 103 degrees Farenheight). On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful) and VACCINATION SITE ERYTHEMA (Injection site is a bright red mark). On an unknown date, the patient experienced VACCINATION SITE PAIN (Painful). On 29-Mar-2021, PYREXIA (Fever went 103 degrees Farenheight) had resolved. At the time of the report, VACCINATION SITE WARMTH (looks like Covid Arm, hot to touch, and painful), VACCINATION SITE ERYTHEMA (Injection site is a bright red mark), VACCINATION SITE PAIN (Painful) and CHILLS (had terrible Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Body temperature: 103 degrees farenheight (High) 103 degrees Farenheight.         Treatment for the events included Prednisone and Antibiotics.  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.   This case was linked to MOD-2021-079925 (Patient Link).; 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.
Patient received second Shingrix vaccine in office on 12/30/2020. Says that the vaccine was extremely painful and that she has continued to have shoulder pain since   Ortho evaluated patient's shoulder, has recommended physical therapy.
After couple day of vaccine, my body itching so much, special my arm, feet and 2 ear.
Difficulties in the arm; Difficulties in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder). At the time of the report, LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) outcome was unknown.            No concomitant product was provided by the reporter.  No adverse events after the first two vaccinations. The patient experienced "Difficulties in the arm" and "Difficulties in the shoulder" after third dose.  The patient was in treatment (unspecified) for multiple myeloma.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324596, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324609 (same reporter). This case involves a female patient of unknown age who received vaccines FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB (expiry date: 31-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-NOV-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and 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 12-JAN-2015, the patient was treated at an urgent care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful 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 and pain and suffering and other damages. Additional information has been requested.
Muscle aches, joint pain, fatigue, chills, mild headache,  scratchy throat.
Swelling, redness, pain at vaccination site. Nausea, vomiting and tinnitus started that night. Tinnitus still present one week later.
On day 8 after receiving the first Moderna COVID-19 vaccine I woke up with a red area around the injection site. The are was about 1 1/2 inches by 2 inches in size. It was hot to the touch and mild itching was noted. On day nine the area had spread to 4inches in diameter. On day ten and eleven it remained the same in size. The redness decreased and there was a significant decrease in the irritation of the area. On day twelve a new area of irritation presented on the the outside boarders of the original area. On day thirteen the are continued to spread involving the majority of the upper left arm. Topical diphenhydramine has been used to help with irritation with minimal relief. Oral diphenhydramine has also been used with slightly better results.
I received my first dose of the Moderna covid-19 vaccination on February 27th and after 16 days I am having a constantheadache and my arm is red and splotchy, warm to the touch and itches.
Fever so far reaching 100.2, headache, neck pain, weakness, skin sensitivity, hair sensitivity, nausea, muscle and joint pain, muscle spasms/cramps with short term weakness.
On 5/10/01, mother noticed redness and induration at injection site. Child said there was no pain, only slight itching. On 5/11/01, redness and induration on right arm below shoulder to above elbow. No crying or fever.
I began having a reaction on the evening of 2/19 with a sore arm and scratchy throat. The next morning, I developed shaking chills, slight nausea, headache, and low grade temp 99-100. I also noticed swollen glands and muscle aches and pain in my back. That lasted about 28 hours. After that I had nerve pain in my neck and all my teeth were painful. I went to bed. I have fibromyalgia so I thought that I may be triggered into a flare. The acute symptoms subsided in a few days, but I then had  intermittent sudden nerve pain, cold spells and hot flashes, a recurrence of irritable bowel like symptoms, with occasional diarrhea (uncharacteristic for my IBS-C). I had to visit my osteopath (for osteopathic manipulation) twice in two weeks for the pain.  She suggested that my symptoms were more than a typical flare and that I should report to VAERS. Yesterday, 3/9 I began to feel exhausted. Last night I had severe systemic  itching that kept me awake much of the night. Today the fatigue continues along with temperature dysregulation. I have contacted my PCP and am awaiting an appointment confirmation.
Day of shot arm became increasingly swollen, by evening site was red, painful.  Unable to sleep well.  2 days later area still red, approximately 1/2 inch long and 2 inches wide and still tender to touch.
Narrative: COVID infection following COVID vaccine series 02/11, Pfizer, dose #1 03/04, Pfizer, dose #2 11/02 COVID swab, result: detected 11/02 pt cc: cough exposure: unknown 11/12 clinically resolved
injection site slightly warm; a liitle rash; red spots at the injection site; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not reported.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness). At the time of the report, VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information was not reported
ED had several ED visits within 6 weeks of receiving COVID vaccination. On 4/18/2021 patient presented to the ED with wrist sprain. On 4/20/2021 patient presented to the ED with acute alcoholic intoxication. On 4/24/2021 patient presented to the ED with suicidal ideation and was subsequently hospitalized. Patient received second dose on 4/29/2021. On 5/8/2021 patient presented to the ED for allergic reaction. On 5/10/2021 patient presented to the ED with worsening allergic reaction symptoms.
allergic reaction to vaccine; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very achy, very warm to touch and itchy; arm is very swollen and red; arm is very swollen and red; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 43-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 08Sep2023 as dose number unknown, 0.5ml single (Lot number: GT0538, Expiration Date: Oct2024) at the age of 43 years intramuscular, in right deltoid for immunisation, Device Lot Number: GT0538, Device Expiration Date: Oct2024. The patient's relevant medical history included: "Anxiety", start date: 2022 (unspecified if ongoing); "Depression", start date: 2022 (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: covid-19 vaccine (dose number unknown (booster); Manufacturer unknown), administration date: 04Jan2023, when the patient was 42-year-old, for Covid-19 Immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to vaccine"; PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "arm is very achy, very warm to touch and itchy"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "arm is very swollen and red". Therapeutic measures were taken as a result of allergy to vaccine, pain in extremity, feeling hot, pruritus, peripheral swelling, erythema.  Additional information: No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Events did not require a visit to the Emergency Room not Physician Office. No family medical history relevant to events. NDC number of Prevnar 20: 0005-2000-01. Reported severe side effect of Prevnar 20. On 11Sep2203, patient sent message stating she was having allergic reaction to vaccine she received Friday. Her arm is very achy, very warm to touch and itchy; arm is very swollen and red. Did not provide when started. Doctor responded "this morning" and recommended patient ice the area a few times a day and take ZYRTEC, CLARITIN, or ALLEGRA daily as needed for the itching. Told her it can take up to 2 weeks for reaction to resolve and let her know if it continues to get worse and mentioned they would report reaction and patient closed case. Patient didn't respond.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
administration of an improperly stored vaccine; No additional AE reported; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number T028929, expiration date 08-MAR-2023, dose 1 (units not provided) (exact dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 27.8 degrees Fahrenheit for 3 hours.
MVX (Manuf); Lot#; Exp Date:  JSN; 042A21A; 06/21/2021 vaccine info Cranial nerve 6 palsy 2 months after vaccine -Sinus pain refractory to his usual ibuprofen/antihistamine began Saturday and  new onset diplopia started Monday -VA 20/20- and 20/20 -IOP 16, 15 -Restriction in right upper, right lateral and right lower gaze of the right  eye. Full EOM OS -Binocular horizontal diplopia that goes away with covering 1 eye -Denies recent illness, GCA symptoms -PMHX hypothyroidism and obesity. No DM or HTN (BP today 142/80 - pt reports his  BP is usually lower) -Anterior exam wnl -DFE without optic disc swelling or obscuration of vessels -Pt has no other FND. CN II-XII intact except for CN VI -Humphrey visual field: full with no defects
Swelling, redness, 2" x 2" no oozing, no blisters. Movement at left elbow, no pain
Chills; Fever; Body aches; Heart palpitations; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 20:00 the patient experienced chills, fever, body aches, heart palpitations and dizziness. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, body aches, heart palpitations and dizziness were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal.  Then around 7am asked to go to ER because the discomfort became pain and moved to the side.  Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.
SUSPECTED CLINICAL VACCINE FAILURE; LONG HAULERS COVID-19; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination (dose number series 1). No concomitant medications were reported.  On 17-NOV-2021, the patient reported that her physician diagnosed her as long haulers covid-19 and suspected clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long haulers covid-19, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number 90000207750.; Sender's Comments: V0 20211240696-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Leg pain in left thigh began about two days after vaccine shot was administered.  Hematoma formed and due to sever pain went to emergency room.  MD did an ultrasound and determined that pain was due to hematoma.  Morphine was given at hospital and Tramadol 50mg was prescribed.
Fever of 101; Achey all over; Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), MYALGIA (Achey all over) and LYMPHADENOPATHY (Swollen lymph node) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036821A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CITALOPRAM, PRAVASTATIN, IBUPROFEN and VERAPAMIL for an unknown indication.   On 10-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) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever of 101), MYALGIA (Achey all over) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, PYREXIA (Fever of 101) and MYALGIA (Achey all over) had resolved and LYMPHADENOPATHY (Swollen lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 101 (High) 101.         Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events was not applicable.
Mild fatigue, general aches & pains, very sore shoulder at injection site, chills, difficulty sleeping due to muscle aches.
Nerve pain on side of right face; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis and migraines. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included secukinumab (COSENTYX), sumatriptan succinate (SUMATRIPTAN), promethazine (PHENERGAN), galcanezumab (EMGALITY) and metoclopramide hydrochloride (PROMET); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 12:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 19:30, the patient experienced nerve pain on side of the right face and the pain came on after the second dose about 29 hours after (as reported). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event nerve pain on side of the right face was unknown at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The second dose I received on 03/24/21 that same day I experienced chills, the next day, late at night, pain began in my legs every day the pain increases, today I went to the doctor due to the pain in my legs, the pain no longer lets me sleep
SUSPECTED COVID-19; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000257354. The suspected product quality complaint has been confirmed to be there was no product quality issue described in the information reported as there was no timeline for date of vaccination to contracting covid, no confirmatory test reported and no indication of symptoms experienced. based on the PQC evaluation/investigation performed.
on 4/9 He said he had flu like symptoms, and dizziness and pain to the point that he could not sleep(he said all of his teammates got sick) on 4/11 He had some much pain in left arm he could not play tennis. He had not been able to play tennis since its been two weeks on 4/17 He went to Urgent Care and they prescribed pain and anitinflammatories He still cannot play tennis