chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TERRIBLE BACKACHE FROM THE BASE OF HER NECK TO THE BOTTOM OF HER BACK; CHILLS; POUNDING HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 53 year old female. 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 not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced terrible backache from the base of her neck to the bottom of her back. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pounding headache. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on APR-2021, and had not recovered from pounding headache, and terrible backache from the base of her neck to the bottom of her back. This report was non-serious.
Nausea, headache, epigastric pain, feeling flushed, metallic taste
I got Covid; I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER7734) and on 17Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing), notes: Celiac. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "I got Covid". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Inflammation scan: Increased. The patient mentioned that she has got the COVID virus at the end of Jan and the end of Feb  and then she mentioned again she can't get this to calm down.   No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of pain in thumb in a 45-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). Concomitant products included ENGERIX B adult. On 10th February 2015, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 1 ml. On 30th March 2015, 48 days after receiving ENGERIX B adult, the patient experienced pain in thumb. On an unknown date, the outcome of the pain in thumb was not recovered/not resolved. The reporter considered the pain in thumb to be unlikely related to ENGERIX B adult. Additional details provided are as follows: On 15th January 2015, the patient received 1st dose of ENGERIX B adult. On 10th February 2015, at 09:31, the patient received his 2nd dose of ENGERIX B adult. About 7 weeks after receiving the 2nd dose of ENGERIX B adult, the patient notified the physician that he experienced pain in his right thumb. On the following week (6th April 2015), the patient visited the physician's office. The physician did find the pain but there was no swelling in the joint. The physician asked the patient to undergo some tests which included X-rays, immunology tests, and rheumatoid panel, but the patient was not compliant and none of these tests were performed. On the day of reporting (15th July 2015), the patient again visited the physician and was still complaining of the same pain in his right thumb and mentioned a little pain in the left thumb as well. On the same day, the patient received his 3rd dose of ENGERIX B adult. The nurse thought that thumb pain to be unlikely related to vaccination with ENGERIX B adult because of the timing and because the patient works all day with a computer keyboard or mouse.
Pt was immunized on 1-24-14 and at the time she did not know she was pregnant. We were made aware on 5-9-14. Pt is 5 months pregnant with EDC on 9-24-14. Sonograms normal.
Pt given flu shot 9-28-12, lot number: Company: Novartis NDC 66521-0115-02 had temp at site of injection with contusion, skin discoloration, redness, soft tissue swelling Lt deltoid at site of injection on evening of 9/28/12. Tx with ice and warm packs until seen 10/1/12. Pt with hx of brain tumor, surgery, chemotherapy that was completed <1 yr ago.
Severe Chills and feverish - 12 hours after shot muscle aches  tiredness headaches 24 hours after shot
Arm started itching at the injection site; Felt tired; Sinus congested; Felt odd that night and the next one and couldn't sleep well; Arm was a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore), VACCINATION SITE PRURITUS (Arm started itching at the injection site) and FATIGUE (Felt tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore) and FATIGUE (Felt tired). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started itching at the injection site). On 03-Mar-2021, SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore) and FATIGUE (Felt tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm started itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided included medication for allergy. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-May-2021 and does not contain any new information.
Steady decline under hospice care which began 1/4/2021 r/t CVA hx. Mild improvment at times with consistent decline throughout until expiration 7/15/21 at facility.
20 minutes after flu vaccine. She felt hot and flushed-face, neck trunk , legs mostly, arms L>R hard initially she felt tingling . No SOB. Afebrile. US stable , flushing subsided over >2 hours. PO Benadryl preivously had fluraccone with reaction.
Discharge Provider: , MD Primary Care Provider at Discharge:  Admission Date: 11/15/2022 Discharge Date: 11/17/2022 COVID positive Date: 11/15/2022 PRESENTING PROBLEM: COVID-19    HOSPITAL COURSE:    Patient is a 76 y.o. female, peripheral neuropathy, osteoarthritis, Barrett's esophagus, anemia and arthritis. She presented to a local hospital on 11/15/2022 with chills, nasal congestion, coughing, sore throat, runny nose x 3 days.  The patient was found to be COVID positive upon admission to the emergency department with hypoxia requiring 3 L nasal cannula supplemental oxygen.  Chest x-ray was performed and showed hyperinflated lungs without any infiltrates.  While hospitalized the patient was treated with Decadron and remdesivir.  She received a total of 2 days of treatment.  Her hypoxia improved quickly with treatment and she will be returning home without additional skilled services. Will continue supportive care with scheduled Mucinex and p.r.n. Tessalon Perles upon discharge. The patient also complained of urinary symptoms and her urine was consistent with UTI. She was started on bactrim which will be continued upon discharge.  Recommend outpatient follow-up with PCP in 1-2 weeks for post hospitalization follow-up and coordination of care.
Pt talking about spiders in her hair and wants them off. She hears something and starts screaming and gets hysterical. She wouldn't go by the mirror because she didn't want to see the spiders. Had low grade fever and hallucinations. Child had middle ear infection apparent only by MRI. Child had been taking Cardene, possible reaction. It was reported that child recovered on 4/6/2000, but pt reported symptoms returned on 4/7/2000.
09/15/22 presents to ED for "chest pain". PMHx of "CAD (on plavix) and previous stents, Ischemic CMP with ICD"
There was a frig temp discrepancy. VFC frig's min. went down to 31. No illness or injury. Pt does need to be revaccinated. Appt 8/15/16.
Pt c/o neck pain when waking, pain radiating to l/shoulder and arm pain so intense pt was transported to hospital by ambulance, treated and released.  Given demoral for pain.
fatigue/flat on my back in bed; chills; injection site reaction lymph node swelling under arm; Fever; Muscle aches; Pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue/flat on my back in bed), CHILLS (chills), INJECTION SITE LYMPHADENOPATHY (injection site reaction lymph node swelling under arm), PYREXIA (Fever) and MYALGIA (Muscle aches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Nov-2020. Concurrent medical conditions included Food allergy (Trout), Hypertension since 15-Sep-1998, Sinusitis since 01-Sep-2014, Obesity (Weight gain due to inactivity.) since 20-Aug-1948, Seasonal allergy since 20-Aug-1956 and Arthritis since 20-Aug-2005. Concomitant products included MONTELUKAST SODIUM (MONTELUCAST) from 15-Mar-2017 to an unknown date for Allergy, MELOXICAM from 15-Oct-2012 to an unknown date for Arthritis, SIMVASTATIN from 20-Oct-2010 to an unknown date for Hyperlipidaemia, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE) from 14-Nov-2014 to an unknown date and AMLODIPINE from 05-Oct-2020 to an unknown date for Hypertension, AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN/CLAVULANIC ACID) from 09-Sep-2017 to an unknown date for Sinusitis.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (fatigue/flat on my back in bed), CHILLS (chills), INJECTION SITE LYMPHADENOPATHY (injection site reaction lymph node swelling under arm), PYREXIA (Fever), MYALGIA (Muscle aches) and VACCINATION SITE PAIN (Pain at the injection site). On 16-Feb-2021, FATIGUE (fatigue/flat on my back in bed), CHILLS (chills), PYREXIA (Fever) and MYALGIA (Muscle aches) had resolved. On 18-Feb-2021, INJECTION SITE LYMPHADENOPATHY (injection site reaction lymph node swelling under arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2020, SARS-CoV-2 test: (Positive) Type of test : Nasal swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-096947 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: This Follow-up was received on 28-APR-2021 which updated patient demographics, lab details, concomitant medications and event details.
Moderna covid-19 monovalent booster administered after 9/2/22. On 9/23/22 monovalent booster administered, no adverse reaction noted.
Initial report received from a nurse on 16 Feb 2011: This patient was vaccinated with MENVEO (batch number A100028) 0.5 ml dose, intramuscularly on 07 Feb 2011. The patient received MENVEO lyophilized powder reconstituted with saline instead of liquid conjugate component on 07 Feb 2011. No other information reported. Follow-up report received from a nurse on 08 Mar 2011: Patient demographic updated. This patient was vaccinated with MENVEO into deltoid. No adverse event occurred after following administration error.
Patient has experienced "sharp persistent pain" in shoulder of the arm the shot was given. Stiffness occurs upon waking. The stiffness goes away after several hours but the pain stays. This has happened daily since 11/1/14.
Left arm soreness initially followed by swollen left supraclavicular node and some anterolateral Chest wall swelling. Initial telemedicine visit then went to urgent care 4/7 .
Multiple marked raised edematous lesions spread over entire body after flu vaccination given. BENADRYL 25 mg PO BID x 3 days. CALAMINE Lotion PRN itching. 125 mg SOLU-MEDROL IM given with follow up ordered 5 days.
She developed a rash with blisters on her Right arm, Down her back and buttocks. Within the 1st 2 weeks of getting the shot. Went to Dr on 8-26-16 - Acyclovir 400 mg 2T PO 5 times every day times 7days - 8-26-16.
This spontaneous report was received from a registered pharmacist refers about 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. Pharmacist reported that she had about 4 patients, over the course of 4 years that she's been vaccinating, who called and complained of having red welt right around injection site after receiving ZOSTAVAX. The outcome of the reported event was unknown. Pharmacist did not have any additional information. This is one of the several reports from the same reporter. Additional information has been requested.
My fingers started tingling with mild pain. I noticed little white spots on my hands & fingers. My finger started hurting really bad, like I had smashed my fingers. I started to get a blotchy red rash on my hand and very fine red rash on my arm.
Lost eyesight. Later dx of MS. WHO causality assessment "B1. Indeterminate. A temporal relationship is consistent but there is insufficient definitive evidence for vaccine-causing event."
Sore arm at point of injection, stomach/bowel discomfort, diarrhea (started on 8/1, 7:00am), hot/cold feeling all day 8/1/2018, tired/sleepy.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost conciousness a few minutes after dose was given. Patient was unresponsive for approximately 2 minutes. Neck felt tight, difficulty breathing, was not alert/oriented when finally awoken. Patient was given 1 shot of epi 0.3 due to a temporary interuption in breathing that lasted seconds. By the time paramedics arrived, he was becoming more alert. Was taken to the ER and discharged.
DRUG INDUCED POLYNEUROPATHY ACUTE DVT, UNSPECIFIED VEIN HYPOTENSION 2/25/2023 -- RECURRENCE OF SAME SYMPTOMS
MENACTRA given 6/21/2010 mom called 6/22/2010 temporal temp 100.5. Body aches, dizzy, weak HA mom said HR 130.
Patient was vaccinated twice within recent days by mistake. Patient mentioned having some arm pain shortly and was evaluated by a provider. Physician mentions patient is stable and has scheduled him for a follow up.
A report has been received from a Pharmacist concerning a nine month old, male patient, who received the Nasal FLUMIST Quadrivalent at a walk-in clinic. FLUMIST Quadrivalent was administered on 16-NOV-2015. Patient's primary care provider saw him after the administration and no adverse effect was noted. As per primary care provider's notes, patient was in a very good condition. The outcome of the event was unknown. The report was considered to be non-serious by the reporter.
first dose in November 2021/came back in 6 months and would like to know how to proceed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (patient received the first dose of Twinrix vaccine in November 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter reported that, the patient should have came in 1 month, but came back in 6 after 1st dose and would like to know how to proceed. The reporter consented to follow-up but did not give information to follow-up as she did not want anything to be sent over in her name. The reporter preferred someone follow-up by phone to the manager of the store, as that was not her regular store. Additional Supportive Information: The reporter reported that, the patient should have came in 1 month, but came back in 6 after 1st dose and would like to know how to proceed, which led to incomplete course of vaccination.
This spontaneous report as received from a nurse via a company representative refers to an 8 year old male child. On 05-SEP-2006, the patient was vaccinated with VARIVAX lot number either 0419R or 0788R dose 1 for vaccination. On 19-JAN-2012 the patient was vaccinated with VARIVAX lot # 0863AA, expiration date 06-JUN-2013 dose 2 for vaccination. No concomitant medications were reported. On 29-NOV-2013, the patient experienced varicella rash. The patient sought medical attention and was diagnosed with a mild case of chicken pox (50-500 lesions) on 03-DEC-2013 by the physician. The outcome of chickenpox was reported as not recovered/not resolved. Additional information has been requested.
My adverse event started on 03/08/2023. In the afternoon I was making soup for Church I started feeling unsteady, my feet/toes were numb, dizzy, fatigue, loss of sensation on my hands, headaches, and over all body aches. My pain was more severe than before. It prevented me doing things that I wanted to do. On 03/10/2023 I went to see my doctor but instead I was seen by a nurse. They did CAT-Scan (brain) the nurse told me that it was not a recent event. It was an old bleed that occurred years ago. The nurse prescribe me with prednisone for 12 days. I had seizures that happen from my birth till my 20's. I still have slight pain as of now along with fatigue.
Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were moved from freezer to Room Temperature at time of vaccination. Vial did not undergo any temperature excursion. Patient did not have any adverse reactions. No treatment  medications were reported.
Case number PHEH2014US016219, is an initial spontaneous report from a health care professional received on 11 Aug 2014. This report refers to an 18-year-old female patient. Past medical history and concomitant medication were not provided. The patient was vaccinated with first dose of MENVEO (batch number: unknown) in 2007, second dose in 2012 and third dose in 2014.  It was reported that the patient received a total of three doses. No adverse event was reported following this medication error.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-OCT-2014, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had one temperature excursion of 72 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
patient stated "quarter-sized, red, hot and it did hurt, felt like a blood pressure cuff not being released from elbow to shoulder. Noticed 1-5-21 after work, felt heavy. Spoke with Nursing Supervisor the morning of 1-6-21. No breathing issues."  Moderna COVID-19 Vaccine EUA
Swelling and lump developed approx. 5inch lump w/ surrounding redness. Swelling decreased overtime w/ ice.
4hr p/vax pt exp chest tightness, light-headedness, nausea, loose bowels;pt also exp a site rxn described as silver dollar sized that was red, hot & white around the periphery;fever, chills, sweating, worsening of gastrointestinal sx, belch
Information has been received from a physician concerning a 16 year old female who approximately "2 months ago" in November 2007, was intramuscularly vaccinated with her first dose of Gardasil.  The patient had a "3 inch by 2 inch indentation" at the injection site that looked as if "all the tissue beneath it had atrophied."  The patient's mother had stated that this began "almost immediately" after the injection.  There is a scar at the site that looks like "the scar from a small pox vaccine".  The physician gave the patient a saline injection at the site of the injection.  The physician would not provide the demographics of the doctor who administered the vaccine, but stated that he can be contacted with any follow up paper work.  Additional information has been requested. 02/12/2010 Follow up information indicated the patient was diagnoes on 14-Nov-2007 with massive skin atrophy in the subcutaneous tissue in the deltoid area on her left arm. The patient's present status is unknown.
Patient had 2 seizures approximately 30 minutes apart, the morning following Pfizer COVID19 booster. Not an epileptic. Husband reports the seizures to pharmacy and states she is now feeling well. No seizures since morning of 1/25/22. Husband was urged to call doctor for evaluation.
Diffuse splotchy erythematous, mildly pruritic rash on arms, neck, trunk, and legs. More prominent on flexor surfaces of limbs.