chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills within 12 hours of second dose; Body aches within 12 hours of second dose; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and dairy. 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 COVID vaccine. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24 FE) and fluticasone propionate (MANUFACTURER UNKNOWN) and lorraine (MANUFACTURER UNKNOWN) ;all for unknown indications on unknown date and unknown if still ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 01:00 as a single dose for COVID-19 immunisation. On 28Apr2021 at 01:00 the patient experienced chills and body aches within 12 hours of second dose. The events 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events chills and body aches within 12 hours of second dose was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pain in arm which received injection 45 mins after injection. 2AM woke up crying, pain in arm, severe headache, ibuprofen given. Aches and pains in joints and muscles. Fever 102.5F. Rash and hives in arm that received injection.
Had an uncontrollable urge to drink alcohol. Significant memory loss following alcohol consumption, totalling 14 hours. Later diagnosed with herpes and syphilis.
Noticed redness and inflammation and administration site, difficulty to raise arm. Redness gradually spread and became larger, came to LBVA to have evaluated. Advised to gentle stretch, apply cold pack take Motrin.
Chronic Fatigue Syndrome; I do not feel like I am alive; Lump on the injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome), FEELING ABNORMAL (I do not feel like I am alive), VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome), FEELING ABNORMAL (I do not feel like I am alive), VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site). In June 2021, VACCINATION SITE MASS (Lump on the injection site) and VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome) and FEELING ABNORMAL (I do not feel like I am alive) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   Reporter did not allow further contact
second dose they stated that they got it on  the 5March2021; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (soar arm). On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (soar arm) had resolved. On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-331446, MOD-2021-331522 (Patient Link).
Patient presents to emergency department on 11/14/2021 following an episode of loss of consciousness. He also has a cough. He was exposed to COVID-19 and did test positive for COVID-19 at admission. He was treated for new onset atrial fibrillation during admission. He was asymptomatic for COVID-19 infection and did not require any treatment. Patient was discharged home on 11/16/2021.
First dose:  24 hours after receiving injection; Fever, chills, headache, sore arm at injection site that lasted approx 24 hrs. Second dose:  10 hrs after receiving injection; Fever, chills, headache, nausea, vomiting lasting 48+ hours.   5 days after second injection:   brain fog with difficulty thinking and feeling of being "spaced out".  Reoccurring light headache, arm rash with itch and discomfort.  Fatigued to the point of being exhausted completing daily chores (grocery shopping, light house cleaning)
SHORTNESS OF BREATH; CHEST PRESSURE/PAIN IN THE CENTER OF CHEST; SORE THROAT; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. The patient received tylenol extra strength tablet (caplet, oral, batch number: SAA006 expiry: -OCT-2023) dose and frequency were not reported from 12-APR-2021 05:00 for headache, and fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced chest pressure/pain in the center of chest. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol extra strength tablet was not reported. The patient had not recovered from headache, sore throat, and fever, and the outcome of shortness of breath and chest pressure/pain in the center of chest was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria), based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Toxic Drug reaction; Severe dehydration, vommitting, diarhea, stomach cramps, muscle cramps, difficulty breathing. Symptoms lasted for 4 days.
The afternoon after vaccine, fever, body aches, chills, hives over entire body, felt hyper.
Tingling nerves down left side of neck, left shoulder, and arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 1, single and administered in arm left, administration date 19Feb2021 09:30 (Lot number: EN6200) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Malignant hyperthermia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Succinylcholine, reaction(s): "Allergies". The following information was reported: PARAESTHESIA (non-serious) with onset 03Feb2021, outcome "not recovered", described as "Tingling nerves down left side of neck, left shoulder, and arm". The event "tingling nerves down left side of neck, left shoulder, and arm" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The event increased after second dose on 19Feb2021. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After vaccination, the patient was monitored for 15 minutes. He reported he was feeling fine when leaving the pharmacy. The patient's relative called in the evening reporting he was having nausea with vomiting. The patient was counselled to seek medical care to manage nausea and take tylenol for body aches. The pharmacist followed up with the patient the next day. Nausea subsided and patient reported feeling fine again. He said he had left message with his doctor and hadn't heard back.
Janssen COVID-19 Vaccine EUA  Chills, fever, upset stomach, fatigue
Tingling, numbness loss of strength in right hand, tiredness, pain in my joints, nerve twitches.
heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced hear failure. On an unspecified date, the patient was treated by a physician for hear failure. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of heart failure was determined to be medically significant.
pt recv vax 27JUN95 & 26NOV96 pt devel a generalized diffuse rash on neck, back, & thighs;it was reported that the rash was coming out slowly, crop-like;
Severe pain in arm in which flu vaccine received, pain has persisted and has required pain meds, muscle relaxers and physical therapy  11/03/09 ICD Codes Received.   11/05/09 Medical records and discharge summary received for DOS 10/11-10/14. Final DX: Anxiety disorder NOS, Joint pain, Problems related to psychosocial environment. Had flu vaccine 2 months prior and developed muscle inflammation, shoulder pain. Pain meds and steroid tx.  D/C steroids and 1 week later developed psychiatric sx. Presented in the ED with depression, suicidal ideation and feeling of crawling under the skin (.tactile hallucinations). Notes waves of depression and cold sweats. Hopelessness, irritability, decreased energy. GAF 32-40. PE WNL.  Psych admit.  Improved. GAF 60.  Prognosis guarded to good. D/C to home.  ICD9: 300, V628.4, 724, 719.41, 531.90, 305
pains on the left side of his body, in his knee and hip; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller was calling on be-half of her husband (patient). The patient has been having pains on the left side of his body, in his knee and hip, after his second dose of the vaccine. The patient's doctor said it may be a side effect of the vaccine. The caller wanted to know if this was a reported side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5 days after vaccine administered, developed local erythematous area which was itchy and grew in size over 24 hrs to 4x3 cm (at time of appt for local reaction 2/2/21)
This spontaneous report was received from a physician via company representative refers to an approximately 5year old male patient. The patient has seasonal allergies, the patient had no drug allergies and he was currently allergic to cashews. The patient was previously allergic to eggs and to cats but outgrew these allergies. On an unknown date in 2007 (reported as at birth) the patient was vaccinated with first dose of RECOMBIVAX HG (lot number, expiry date and route was unknown). On an unknown date, the patient was vaccinated with second dose of RECOMBIVAX HB (lot number, expiry date and route was unknown). Concomitant therapies included CLARITIN. Approximately on an unknown date in 2013, the patient experienced eczema and alopecia. The office manager first noticed a patch of missing hair on her sons scalp in July 2012 when he had a haircut. She stated that her son used to have thick curly hair. However currently he has no hair on head and body including no eyebrows. He went to the doctor who diagnosed him with tinea capitis and was treated with griseofulvin which did not help. He then switched to another physician who treated him with an unspecified antifungal cream which did not help. He then switched to another physician who said that tine capitis was a misdiagnosis. She then diagnosed him with alopecia and eczema. The patient was prescribed with Retin A and Rogaine as a treatment. The patient tried for a month and discontinued them because they did not help. Antibody testing, gluten testing and lead poisoning testing was performed. The outcome of the events were reported as not recovered. The patient sought medical attention. This is one of the two reports received from the same reported. Additional information has been requested.
Refridgeration excursions identified; No adverse event; Temperature excursion product administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no allergies.  It was unknown that the patient ever been diagnosed or tested positive for COVID-19.     On 26-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion product administered to the patient).    No concomitant medication was provided.  On an unknown date, the patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses.  The patient had received dose 4 on deltoid body site.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The refrigeration excursions identified; state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic where was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
2 days p/vax pt woke w/the room spinning around;this persisted to a lesser degree for about 2wk;
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
pt recv vax & exp chicken pox; had about 40 pox marks all over body; No further details were provided;
-Swelling lower inside bicep (large bump) -Red patch along swelling & around bicep -warm to touch -Soreness at vaccination site
TIRED; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose Number in Series: 1) (suspension for injection, route of admin, and batch number were not reported expiry: Unknown) dose was not reported,1 total administered in12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications were not reported.  On 12-MAR-2021, the patient experienced tired. (Dose Number in Series: 1)   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 15-Mar-2021.  On 01-Nov-2021, the patient received non-company vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported expiry: Unknown) dose was not reported,1 total administered on vaccinated on right arm for prophylactic vaccination. (Dose Number in Series 2).  The patient had not reported any adverse events following vaccination with MRNA 1273. (Dose Number in Series 2).  The action taken with MRNA 1273, was not applicable.  This report was non-serious.
Patient came in and said arm sore and stiff where had shot from 9/27/13. She reported arm soreness 11/17/13, Sunday 1 pm. No redness or rash reported. Referred to Physician.
This spontaneous report was received from an office manager concerning unspecified patients of unknown age and gender. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On an unknown date (reported as "between the months of "May to July""), the patients were vaccinated with improperly stored GARDASIL 9 lot # N017697, expiry date: 21-JAN-2020 and LIQUID PEDVAXHIB lot# N024572, expiry date: 02-MAY-2020 for prophylaxis (dosing details not reported for both). No adverse effects were reported. Time frame of temperature excursion were from 32 degree Fahrenheit to 35 degree Fahrenheit for 192 hours and 47 degree Fahrenheit to 77 degree Fahrenheit for 122 hours 30 minutes. Previous temperature excursion was 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours. Data logger was involved. No product quality complaint (PQC) was involved.
This spontaneous report as received from a pharmacist refers to a female patient with hypertension, anxiety, degenerative arthritis and sulfonamide allergy. Approximately in 2005 ("about 7 years ago"), prior getting PNEUMOVAX 23, the patient had received TD vaccine and experienced an arm rash at the injection site. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot number, route and injection site not reported). Concomitant medications included omeprazole, citalopram, hydrochlorothiazide, naproxen and amlodipine. On an unknown date the patient experienced an arm rash at the injection site. The patient did not receive treatment. On an unspecified date the patient recovered from the arm rash at the injection site. Additional information has been requested.