chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed an escalation in the intensity of my (relatively minor) tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9261) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no Known allergies. Concomitant medication(s) included/Other medication in 2 weeks: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. The following information was reported: TINNITUS (non-serious) with onset 22Jan2021 at 20:00, outcome "not recovered", described as "developed an escalation in the intensity of my (relatively minor) tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Adverse event: Approx. three hours after receiving first shot on 22Jan2021 patient developed an escalation in the intensity of her (relatively minor) tinnitus.
Woke up about 9:00 pm with widespread hives, even in her ears, face, chest, legs, eyes were swollen shut, and she was very itchy. Mom gave Benadryl q6 hours and the rash started going away and swelling went down. Mom reported to office the following morning, 12/10/2013. Mom was advised to continue to monitor and go to Emergency Dept if patient has any difficulty breathing, facial or oral swelling, or difficulty swallowing. Mom stated at another visit after this event, 07/08/2014, that patient experienced shortness of breath at the time the hives were present as well.
five (5)  hives on her body; itchy hives/itching; she could not sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night) 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.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night). At the time of the report, URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Resident was off work 2 days plus weekend was very fatigued, had fever, chills, headache and muscle aches like she had the flu.
Neck became stiff where he could not turn his head, or had difficulty moving his head; Trouble swallowing; Tenderness around the base of the skull on right side/Tenderness below the jawline on the right side/Tenderness down the right side of the neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 23Feb2021 15:00 (Batch/Lot Number: EN6200, expiry date: unknown) as dose 1, single (age at vaccination:67-Years-old) for COVID-19 immunisation. Medical history included ongoing diabetes mellitus 25 years ago, around 40 years of age, ongoing hypertension 25 years ago, around 40 years of age. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 16:00 the patient experienced neck became stiff where he could not turn his head, or had difficulty moving his head, trouble swallowing, tenderness around the base of the skull on right side/tenderness below the jawline on the right side/tenderness down the right side of the neck. This consumer was administered his first dose of the Pfizer COVID-19 Vaccine on 23Feb2021 around 15:00 and everything was fine. Starting 24Feb2021 around 16:00 his neck became stiff where he could not turn his head, or had difficulty moving his head; trouble swallowing; he also had, only on the right side: tenderness around the base of the skull on right side; tenderness below the jawline on the right side; and tenderness down the right side of the neck. He thinks the areas with the tenderness could be lymph nodes but he has never had problems with lymph nodes in the past. He asked if this is a normal effect of the Pfizer COVID-19 Vaccine or if it would be considered serious. The events not resulted in emergency room visit/ Physician office visit. On 04Feb2021 the patient underwent lab tests and procedures which included magnetic resonance imaging: bulging disc in lower back. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Expired vaccine was stored and then administered/Vial refrigirated after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 18-Oct-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/inj;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by a pharmacist;
Muscle cramps and nerve pain- cramps in legs and arms. Nerve pain (or sharp, pinching pain) in legs, arms, hands, feet, and sometimes jaw and sides.
Pt states approx 2 hrs p/vax was given, pt began having a fever of 101 to103 & a chill & aching severly; pt was taken to Hosp ER & admitted; This was pts 1st flu immun;
The first couple of days had a fever, light-headed, pulsating feeling through my body, and feeling faint at times.  Symptoms go away after the third day.  Then nearly two weeks later the feeling of being light-headed, pulsation sensation throughout my body, and feeling faint at times came back.  It's been a few days of these symptoms returning and it has me concerned.
Throbbing glands Swollen lymph nodes  throbbing glands tender to touch
Heavy legs(walking thru quick sand), sudden onset sweating, metallic mouth, extreme fatigue, migraine headaches, loss of concentration
No addittional adverse events reported; EXPIRED RECOMBIVAX HB ADMINISTERED; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 10-MAR-2022, the patient was vaccinated with an expired Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliters (mL) administered intramuscularly (IM) as prophylaxis (lot number reported and validated as S002769, expiration date reported and stablished as 04-NOV-2021) (strength, vaccination scheme, anatomical location was not provided). No other adverse events (AE) reported (no adverse event).
Powder vial reconstituted with sterile water; Powder vial reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA977A, expiry date 31-MAY-2024) for prophylaxis.   On 10-APR-2023, the patient received the 2nd dose of Menveo. On 10-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Powder vial reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Powder vial reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 11-APR-2023 The nurse practitioner noticed that they have an extra vial of Menveo vaccines.  The nurse have a potential 18 year patient that could has probably received Menveo powder vial reconstituted with sterile water from another vaccine. Follow up accepted but health care practitioner (HCP) prefers a first contact by phone. The reporter consented to follow up. The patient that could has probably received Menveo powder vial reconstituted with sterile water from another vaccine, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
PATIENT HAD RECEIVED THE VACCINE 16 DAYS AGO AND STILL HAS A LOT OF MUSCLE SORENESS AND SOME MINOR PAIN WHEN LIFTING HER ARM UP (E.G. PUTTING ON A SHIRT).
She is also diagnosed with rheumatoid arthritis; She started experiencing gout; She is complaining sever muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, FUROSEMIDE, LORAZEPAM, LEVOTHYROXINE SODIUM (SYNTHROID), COLECALCIFEROL (VITAMIN D3), PROBENECID, ESOMEPRAZOLE, TIZANIDINE and COLCHICINE (COLCRYS) for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis) (seriousness criterion medically significant), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (She is also diagnosed with rheumatoid arthritis), GOUT (She started experiencing gout) and MYALGIA (She is complaining sever muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include steroids.  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.; 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.
Bad headache on 8-26 following shot. Headaches continued 9-5 saw Dr. 9-10 did CAT Scan. 9-11 did MRI. 9-26 got up and had memory loss of what had gone on for past day. Dr said go to ER. There 5 hours running tests memory came back. Saw Neurologist 10-3. Ordered MRA 10-1 did MRA. 10-7 did Lumbar puncture which stopped headaches for now.
This is a spontaneous report from a contactable nurse. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced blurred vision and diplopia on an unspecified date. The outcome of the reported events was unknown. Causality was not provided. No follow-up attempts possible. No further information expected.
Pregnant and received both doses of the Moderna Covid 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-May-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine). On 22-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Follow up received and added vaccine first dose details
Fever 104, difficulty breathing, swelling in lips.  1 cc dexamethasone given IM.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Shot was at 11:35 am.  Symptoms began at about 5pm.  Started with moderate headache and muscle aches. A few hours later, chills, shaking, significant achiness and fever of 102. Symptoms persisted into the morning and began to subside about 24 hours after shot.
Fever of 101 from 10/17 to 10/20,  large area of redness with streaks down the arm, arm swelling and headache.
This spontaneous case, initially received from other health professional on 04-Sep-2018, concerns a 79-year-old, elderly, female patient. The patient's current conditions included hypertension, chronic obstructive pulmonary disease and anxiety (reported as medical history). The patient's concomitant medications included Losartan w/Hydrochlorothiazide and acebutolol for hypertension, albuterol, SINGULAIR, ANORO for chronic obstructive pulmonary disease and WELLBUTRIN XL for anxiety. It was reported that, vaccines bring to the pharmacy at room temperature (first time excursion). On 04-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, batch number: 250791, expiry date: 30-Apr-2019, route of administration and anatomical location: not reported] which underwent temperature excursion. No adverse event was experienced after vaccine administration. The reporter assessed the case as non-serious.
Patient complained of feeling light-headed after receiving her third Gardasil dose, was placed in a supine position and observed for 15 minutes, and felt back to normal and was ambulatory upon leaving the office.  She called back on 7/26/2010 complaining of persistent pain in her left upper arm since receiving the vaccine and stated the pain was not relieved with Tylenol.  She denies erythema or swelling at the injection site, fever, or other complaints.  She was advised to try ibuprofen or Aleve, apply heat to the site, and to follow up if the pain does not resolve.
Child received MMRV on 10-25-13. Within 10 minutes, child itching, wheezing. Oxygen level decreased to 88%. Given EPIPEN JR, XOPENEX, DECADRON, BENADRYL, transported to ER. Child had previous severe reaction to egg, but tolerated MMR and varicella in allergist's office. Had flu vaccine also in 2010, 2011, 2012 without reaction.
Case number PHEH2016US004632, is an initial spontaneous report received from a health  care professional on 23 Feb 2016. This report refers to a 79 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515001) intramuscularly on 19 Oct 2015. It was reported that the patient inadvertently received a second dose of FLUVIRIN (batch number: 1515001) intramuscularly on 23 Feb 2016. No adverse event was reported.
Chills, Fever, Racing Heart, Frequent Vomiting, Headache, Lower Back Pain, Hip Pain, Lack of appetite, tiredness and muscle aches lasting a full 24 hours. It started about 6-8 hours after vaccination.
Noticed some soreness at the injection site 8 days after receiving the vaccine.  While showering I saw the shoulder area was red and itchy.
Telephone call received from patient on 11/10/2006 at 10:30AM, reporting the following reaction to the Influenza Fluzone vaccine: numbness in joaw and erythema in neck, face, and jaw. Denies any other anaphylactic reactions.
As soon as I stood up to leave, my neck and throat felt like it was tightening, my head felt full and woozy, I felt felt like I might faint and asked to sit back down in the vaccine room. As soon as I sat, my lower back started hurting. After a few minutes, I started feeling better. The person that gave me the vaccines told me to go sit in the open area ?so she could see me if I passed out?. I said I felt a little better; she said my symptoms were due to low blood sugar, and asked when I last ate (2 hours prior).  After the vaccines but before standing up, she told me I didn?t get Fluzone as shown on the paperwork given to me because they were out of it, so she took the paperwork back. She also stated that she wished she had smaller needles but they were all out. I sat in my car for 5-10 minutes, then drove home.
Several minutes after vaccination, patient experienced syncope.   Patient laid down and recovered on his own.  No intervention needed and patient was able to drive home.
Pt got flu shot on 9/13/11; she came in pharmacy 10/19/11 and claim her arm is swelling and pain since 9/14/11. She still have a lump in her arm now. Pt taking ibuprofen for pain.
Information has been received from a registered nurse concerning an 8 year old male with no medical history or allergies who on 08-FEB-1999 was vaccinated with an SC first dose of Varivax (lot # 628246/1655H). There was no concomitant medication. There was no illness at the time of vaccination. Subsequently on 15-OCT-2006 the patient developed chickenpox and a temperature of 100.9 degrees. The patient was seen in the office on 16-OCT-2006 and had approximately 100 lesions on his trunk and face. The lesions on his face were red and flat, whereas the lesions on his trunk were red and raised. He was treated with CALAMINE LOTION. On 23-OCT-2006 the patient was much improved and the remaining areas were scabbed over. Subsequently the patient recovered. No laboratory tests were performed. There was no product quality complaint involved. Additional information is not expected.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical facility consulted with the Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
anaphylaxis-swollen face, "throat tight" Given Epinephrine by EMS. Seen in ED D/C home on Medrol dose pack.
Pt. c/o headaches that are somewhat resolved with advil ever since he started taking the Typhoid capsules.
4/4/2021 nausea,vomiting,fatigue,sweating,headache. 24 hours.
8/28/02 7:15 L shoulder pink, firm to touch. 3pm red, warm to touch, firm size of half-dollar. 8/29/02 7:15a L shoulder red, hot to touch, very firm. 3:15 same as 7:15a 8/29/02 assessment. MD visit scheduled 8/30/02 at 10:15a.