chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hardness an pain on shoulder; swelling on the shoulder; Pain at the injection site; Chills; Joint and shoulder pain; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hardness an pain on shoulder), SWELLING (swelling on the shoulder), VACCINATION SITE PAIN (Pain at the injection site), CHILLS (Chills) and ARTHRALGIA (Joint and shoulder pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Hardness an pain on shoulder), SWELLING (swelling on the shoulder), VACCINATION SITE PAIN (Pain at the injection site), CHILLS (Chills) and ARTHRALGIA (Joint and shoulder pain). On 19-Feb-2021, VACCINATION SITE PAIN (Pain at the injection site) and CHILLS (Chills) had resolved, ARTHRALGIA (Joint and shoulder pain) had not resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Hardness an pain on shoulder) and SWELLING (swelling on the shoulder) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Email ID added. Non significant
pt recvd vax 28FEB95 & had an onset of light rash on torso & arms; 7MAR95 t103.7 x 3 days; mom called MD who instructed mom to give APAP & watch pt;
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) ongoing since an unknown date at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; AMOXICILLIN ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and negative (Negative) negative.     No relevant concomitant medications were reported.  The patient was exposed to someone who has Covid-19 and he feels like the patient had Covid-19.The patient had gone to Urgent Care and prescribed with Flonase nasal spray, Zyrtec, Amoxicillin, Prednisone and Albuterol Inhaler.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-266012 (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 event, a causal relationship cannot be excluded. Further information has been requested.
fainted; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received BNT162B2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, approximately 8:40 AM, the patient fainted while waiting after receiving the Pfizer/biotech Covid vaccine. The patient was observed and was evaluated by EMT. She was released around 9:20 AM. Outcome of the event was unknown.  Amendment : This follow-up report is being submitted to allow appropriate reporting to health authorities.  No follow-up attempts are possible; Information on the lot/batch number could not be obtained. No further information is expected.
Strong flu symptoms such as horrible body aches, fever 102.1, digestive issues, weakness/fatigue
Headache, Myalgia, chills, malaise, runny nose Narrative:
Approximately 5 minutes after vaccination,  while pt was in our waiting area in front of pharmacy, he started to feel light headed/dizzy.  He stated he was tachycardic.   I had pt sit down immediately.  We called 911.  I took his blood pressure which was considerably elevated (235/107).  Pt had no other signs of an allergic rxn. Paramedics arrived and took pt to the nearest hospital.
14yo female had syncope after Pfizer 1st dose. Her dose was given at approximately 1:10pm. Around 1:18 pm she complained of feeling dizzy and began to pass out momentarily. She came back to quickly. She was given a cold pack for her neck and ammonia inhalant. She wanted to lie down and extended across several chairs with her head upon her guardian's lap. We gave her a second cold pack to apply to her face as well. We gave her some water too. She began to relax and recover. We watched her an additional 20 minutes until she felt recovered and then left with her guardian.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the HCP mentioned because of miscommunication as a coworker told that there were some lot number whose expiration dates had been extended, patient received expired dose. The patient received second booster dose. No treatment information was reported.
Case number PHEH2015US000679, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Pt recvd 1st Engerix-B vax 29JUL91 & exp, that same day, induration less than or equal to 20 cm in 24 hrs, hot to touch, pain & itching for 2 wks; treated w/Pred & DPH;
Swelling, redness, medium size blister at one site, small blister at second site, mild nausea, mild headache, chills, low grade fever comes and goes, aches, arm hurts moderately, fatigue, cloudy feeling
Left arm red swollen hot induration postive mild edema. Benadryl given.
gave doses from an open vial over approximately 2-3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days). At the time of the report, PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Retinal hemorrhage morning of 11/30/2021, followed by persistent and constant visual disturbance (flashing scotoma) from 12/8/2021 and continuing to present (12/15/2021). Concurrent pain behind the same eye from a few days after the vaccine booster until two weeks later.
Covid monitoring documentation. PT admitted 1/6/22 documented to have positive covid. PT received Pfizer 1/8/21 Lot EL1284 for dose 1. Dose 2 was Pfizer given on 1/29/21 Lot EN5318. PT received Pfizer Booster on 11/16/21 Lot FH8027.
Information has been received from a registered nurse concerning a 32 year old male with sulfonamide and penicillin allergy who on 12-NOV-2007 at 1300 was vaccinated intramuscularly into the right deltoid with his first dose of RECOMBIVAX HB (lot# 0762U). There was no concomitant medication and no illness at the time of vaccination. Thirty minutes after vaccination, the patient experienced diffuse hives. Medical attention was sought by the patient, and he was treated with 50 mg of BENADRYL. Subsequently, the patient recovered from diffuse hives on 12-NOV-2007. The nurse considered the patient's diffuse hives to be an other important medical event. No further information is expected.
Case number PHEH2014US025152, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 55 years old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The nurse reported FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Swelling and red patch at injection site (still expanding). Headache x 4 days (till Tuesday). Stiff Neck.
Flu like symptoms, chills, body aches, headache, fatigue, lethargy. Treated with pain meds.
got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster; got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (one dose of primary series of Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster), INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster) and INTERCHANGE OF VACCINE PRODUCTS (got one dose of the primary series of Pfizer/ended up getting the Moderna Bivalent booster).    No Concomitant medications were provided. It was reported that patient got one dose of the primary series of Pfizer. The reporter mentioned that it was entered in the computer wrong and patient ended up getting the Moderna Bivalent booster.  No treatment medications were provided.
Standard title-emergency dept note date of note-Feb 24. 2008@ 22-29-19 Entry date-Feb 24, 2008@22-29-19. Chief Complaint-left arm pain. Present illness-This is a 51 yo. MALE, came to ER with-pain to the left arm where he got a pneu vaccine a few days, has redness and severe tenderness, no fever or chills. Allergies-SEAFOOD, TOMATOES, PINEAPPLES Physical exam-Extremities-No edema, left arm there is tenderness swelling and erythema. Assessment-cellulitis. Plan-ROCEPHIN 1 gm IV now. I liter normal saline. SEPTRA DS. Final disposition-Discharge. STANDARD TITLE-PHYSICIAN ASSISTANT NOTE DATE OF NOTE-MAR 19. 2008@12-11 ENTRY DATE-MAR 19, 2000@12-11-08 AUTHOR Present illness-This is a 51yo, MALE came to ER with-left arm pain since cellulitis, dx here in ER on 2/25. Pt with some night sweats, but is receiving amoxicillin for thorax infection that was dx. Pt with no further swelling of site, no further erythema, just pain. Pt with some stiffness in extremity, but normal sensation. Pt tx. ony with moist heat. STANDARD TITLE-PRIMARY CARE PHYSICIAN NOTE DATE OF NOTE-MAR 25. 2008@ 13-15 ENTRY DATE-MAR 25, 2008 @ 13-15-04 AUTHOR. He is still having some localized left upper arm tenderness following his significant reaction to the PNEUMOVAX injections. Symptoms: Symptoms:1. Angioedema 2. Skin Rash 3. Erythema Multiform. Treatment Drugs Used: 1-CEFTRIAXONE Dose:1 Units: GM Freq: ONCE Route: IV. 2-SODIUM CHLORIDE Dose: 1000 Units: ML Freq. ONCE Route, IV 3-SULFAMETHOXAZOLE/TRIMETHOPRIM Dose: 1 Units: TAB Freq: BID Route: PO. Follow-up Information 27-OCT-2008: Swelling of arm, fever, erythema.
Decreased responsiveness, paleness responsiveness about 3-4 hrs. Called MD on call sent to ER-observed administered PO Phenergan
Left lateral thigh is with an area of erythema with a vesicular eruption, There is a clustered aea of these vesicles that are crusted over and then 3 solo vesicles that are crusted over as well.  There is a slight erthema surrounding the vesicles. but no warmness and it is not extending past the local area.  There is a slight induration around the vesicles as well.
headache and dizzy for two months, then dispeared after some medicine doctror prescribed, but on july 23rd 2021, louder tinnitus on both ears appear, the tinnitus lasts till now. bad sleep always.
Therapy non-responer, Pharmaceutical product complaint.  This case was reported by a physician and described the occurrence of a 62 year-old male subject not responding to therapy following vaccination with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject has no significant medical histoy or concurrent medical conditions. Concurrent medications were not known.  On 30 September 2005 the subject received unspecified dose of Engerix-B (lot number AHBVB135AA, expiration date not provided) at 20 mcg. It was not know if the subject had completed the Engerix-B series.  In 11 July 2006, after vaccination with Engerix-B in September, the subject was tested for hepatitis B surface antibodies and was found to be negative.  The subject had not responded to therapy with Engerix-B. The reporting physician was questioning the efficacy of the Engerix-B lot. No additional details were known at the time of reporting.
Pt developed less than 50 pox. A sibling, brother, developed less than 50 pox. Had been previously vaccinated about 1 year ago.
Information has been received from the authors in a published literature article, title as above, regarding 16 (also reported as 55% of 28 patients) adolescent or young adult patients of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patients were vaccinated with a dose of MMR II (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, Despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and <0.7o IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR II (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same source (MARRS#1601USA010845, 1601USA01937, 1601USA010935). Additional information has been requested.
had vax @ 930 started screaming non-stop crying @ 1015; did not stop to eat; taken to MD 3; still crying; given DPH; also had APAP; cried off & on q 1/2-1 hr throughout noc; t101-102, fussy;
On February 1, 2022, I had a grand mal seizure with no family history of seizures or epilepsy.  I had to have emergency intervention and went to the ER.  I then had a second seizure on April 12, 2022, and had to get on medication.  Having the Covid Booster on January 24, 2022 and then the seizure on February 1, 2022 seems a probable connection.
On 04/01 I contacted the medical group. I had severe cough, low grade temperature, chills, congestion body aches and a fever. The doctor started treating the with two extra strength TYLENOL and PAXLOVID, tromethamine DM lots of water and rest. I was told to retest 5 more day and I tested on the 5th day and was negative. I still have a little cough which I think it's just allergies.
Information has been received from a registered nurse concerning a 6 year old female who was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck). The patient developed a localized reaction at the injection site. The nurse described the reaction as lesion like rash with swelling and erythema. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
swelling at the injection site; red and swollen and painful at the injection site; red and swollen and painful at the injection site; did not feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 13:00 (Lot number: FF8841) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose- 03Feb2021, it was in the afternoon in her left arm, Lot- EL9269, There were no problems after these shots.), administration date: 03Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "There were no problems after these shots."; Bnt162b2 (Second dose- 24Feb2021, it was given in the afternoon in her left arm, Lot- EN6202., There were no problems after these shots.), administration date: 24Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "There were no problems after these shots.". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 11Oct2021, outcome "not recovered", described as "swelling at the injection site"; MALAISE (non-serious) with onset 10Oct2021, outcome "not recovered", described as "did not feel well"; INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "red and swollen and painful at the injection site". Therapeutic measures were not taken as a result of vaccination site swelling, malaise, injection site erythema, vaccination site pain.  Additional information: The patient had swelling at the injection site for 2 days and she has never reported anything like this before.The swelling was just noticed today and she remarks it is red and swollen and painful at the injection site.   No follow-up attempts are possible. No further information is expected.
Starting 3 hours after receiving the vaccine, I developed an ocular migraine in my line of sight. Normally they would last 15 min in the dark, but this one lasted for over an hour (which made me very concerned). When I came out of the bedroom into the light, it came back again. Normally I would only get one episode, but this time it was re-occurring all day. I ended up having to put my sunglasses on indoors to tolerate light. Also, I took Excedrin migraine to alleviate the symptoms. This lasted for about 24 hours. By the next day, I felt better, and the ocular migraines were no longer present. I have not gotten the booster due to my side effects from the first two doses, and prior COVID infection (08/2020). Also, per my doctor's recommendation I have been taking turmeric for my inflammation as a response to previous COVID infection and arthritis.
Information has been received from a nurse practitioner (NP) concerning a 22 year old female with drug allergy to levofloxacine (LEVAQUIN) and no pertinent medical history who on 28-MAY-2008 and 23-JUL-2008, was vaccinated intramuscularly with her first and second 0.5 ml doses, respectively, of GARDASIL vaccine (yeast) (Lot # of the second dose: 659964/1978U). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING) and escitalopram oxalate (LEXAPRO). On 24-JUL-2008 the patient experienced flu-like symptoms and muscle pain. At the time of the report, the patient's flu-like symptoms and muscle pain persisted. The patient sought medical attention by calling office. Additional information has been requested.
Headache, Myalgia, chills Narrative:  patient was at home and symptoms resolved on their own. patient reports mild symptoms.