chrisvoncsefalvay/vaers-outcomes huggingface dataset:
generalized pain/she needs to lay in bed because of the pain experienced and even be in bed results painful; I cannot really do a lot of work because it like walk more than about an hour; like house hold stuff, cleaning and whatever; I just exhausted; Every time I take shower my skin hurts, my scalp hurts; I cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "generalized pain/she needs to lay in bed because of the pain experienced and even be in bed results painful"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "I cannot really do a lot of work because it like walk more than about an hour; like house hold stuff, cleaning and whatever; I just exhausted"; PAIN OF SKIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Every time I take shower my skin hurts, my scalp hurts"; INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "I cannot sleep". Therapeutic measures were taken as a result of pain, fatigue, pain of skin, insomnia.  Additional information: A Consumer calls for information about if she should be vaccinated considering the side effects she developed for the administration of the first dose of the Pfizer COVID-19 vaccine. The Consumer reports that she was administered with the first dose of the Pfizer COVID-19 vaccine 15 days ago and after that she experienced generalized pain that continues up to this day. The Consumer reports that she needs to lay in bed because of the pain experienced and even be in bed results painful, she cannot walk for a distance because of pain and exhaustion and she needs to take a rest before she can continue, the Consumer reports that even the water from the shower hurts while she is taking a bath. Consumer stated, "Well, I took my vaccine about 15 days ago. I am still aching and I am in pain. Every time I take shower my skin hurts, my scalp hurts. The Consumer reports that she is taking Tylenol for the management of the symptoms. The Consumer reports that she is scheduled for the administration of the second dose on 31Mar. When paraphrased the above concern, Consumer stated, "Right. I am just wondering what to do? Is like every day you know I am just in pain. I am just worried I guess."  No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 25 year old female who was vaccinated with the second dose of GARDASIL vaccine (yeast). The patient developed nausea, vomiting and "loss of bowel control" about 19 hours after receiving the vaccination. This was followed by a headache that lasted for 3-5 days. The patient sought unspecified medical attention. Additional information has been requested.
CVA within 9 hours of booster. Vision loss in right eye. Occipital lobe lesion on CT.
50 mm x 30 mm raised red area to arm where MMR now given 24 hors prior.
Hives, itching, difficulty breathing, fever, body/joint pain, head pain, diarrhea  Antihistamines,  fluids,  tylenol Most symptoms eased in 1 wk.  Joint pain continues,  shortness of breath
Yesterday morning, patient woke up with some abdominal pain. His parents thought that the abdominal pain might be related to constipation since he has a history of this and he also had a couple of hard stools yesterday morning. He has been having a lot of problems with his asthma recently so pulmonology and Dr. wanted him to get the PNEUMOVAX. Patient got this vaccine yesterday morning. After getting the shot, he seemed okay but then started vomiting a couple of hours later. He vomited several times. His parents had already given him some MIRALAX because of the presumed constipation. He then started getting diarrhea. At around 5 PM, Dad noticed some red circles around his face. Slowly, this rash spread into a full body rash. The rash is very itchy. His parents took him to the ED and they monitored him and made sure he was getting BENADRYL. He has been taking BENADRYL every 6-8 hours since the rash began at a dose of 25mg. The BENADRYL does not seem to be helping very much as the rash continued to worsen after they got home from the ED. His appetite is still decreased. He has had no swelling or tingling of the lips or tongue and no shortness of breath. No fever.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-MAR-2017, the patient inadvertently received an expired dose of PROQUAD subcutaneously, lot # L032757 with an expiration date of 24-FEB-2017 (exact dose and anatomical location were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Patient went to clinic and was diagnosed with a skin infection caused by Staphylococcus.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Localized headache/eye pain in my right eye. The eye muscle was sore when I moved my eye, especially looking down. Sharp throbbing pain intermittently lasting approx. 2 seconds in right temple. Tylenol eased the pain some. Headache gone the next day but still right eye muscle discomfort the following day and then it was gone.
This case was reported by a consumer and described the occurrence of raised rash in a 55 year old female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included "eczema resulting from food allergies, specifically to bread products," and renal failure due to chronic kidney disease, requiring hemodialysis. The subject stated that she received "several other (concurrent) medications," however, specific medications and indications were not provided. On an unspecified date before 24 June 2005, the subject received the 1st dose of Engerix-B. The subject reported that she, "had no reactions or problems after that dose." On 24 June 2005 the subject received 2nd dose of Engerix-B. On 27 June 2005, 3 days after vaccination with Engerix-B, the subject experienced "a bumpy, itchy rash" on her chest, arms and abdomen. The subject treated the rash with "topical powder." The subject reported that, "the rash lasted for about 3 weeks and then cleared" and that she, "did not consult a physician regarding the rash." The date that the rash resolved was not reported.
This case was reported by a nurse via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included MMR vaccine. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, muscle pain and fatigue. On an unknown date, the outcome of the chills, muscle pain and fatigue were recovered/resolved. The reporter considered the chills, muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient also received an MMR that same day of SHINGRIX vaccine. The nurse reported to sales account manager that her husband received SHINGRIX within the last couple of weeks and on that evening of the vaccination, he experienced muscle aches and chills that night, but then also within a day he experienced fatigue. All his events were resolved on an unspecified date. This case linked to US2018GSK102897, reported by the same reporter.
vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-May-2021. Concurrent medical conditions included Headache, Obesity, Hyperlipidemia, Prediabetes and Hypertension. Concomitant products included LISINOPRIL for an unknown indication.    On 07-Sep-2021 at 2:37 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
pt recv vax OCT96 & 24DEC96 pt started having fatigue & a sl fever for over 1wk & a cough that lingered;pt has recovered;
The first Pfizer shot was on 4-1-21, and I had no reactions to that.  The second Pfizer shot was on 4-22-21, and a few hours after, I started feeling soreness in my arms, shoulder, neck, armpits and had chills (although no fever).  Throughout the next couple of days, the chills and body aches went diminished and/or went away--except for my left armpit.  My left armpit is still sore and it is swollen (now at 52 hours).
My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.
Moderna COVID 19 Vaccine EUA  Hospitalized for productive cough, weakness and headache. Nasal congestion, hoarse voice. Aches and pains to bilateral lower legs. COVID negative. Dx acute viral bronchitis
Eczema; Erythrasma; Redness/erythema; Itching/pruritus generalized; Rash generalized; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021. The most recent information was received on 16-Jul-2021 and was forwarded to Moderna on 16-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema), ERYTHRASMA (Erythrasma), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A1B and 006M0A) for COVID-19 vaccination.     Relevant medical history information was not provided.  The patient's past medical history included Drug allergy (codeine), Drug allergy (Simvastatin) and Drug allergy (Fluvastatin). Previously administered products included for an unreported indication: NIACIN. Concomitant products included OMEPRAZOLE, CETIRIZINE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], PAROXETINE, COLECALCIFEROL (VITAMIN D3), ATORVASTATIN, METOPROLOL TARTRATE, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), ERYTHRASMA (Erythrasma), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized). The patient was treated with COAL TAR (topical) for Eczema, at a dose of 1 dosage form; PREDNISONE on 07-Feb-2021 at a dose of 4 mg and DOXYCYCLINE HYCLATE on 07-Feb-2021 at a dose of 100 mg. At the time of the report, ECZEMA (Eczema), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalized) and RASH (Rash generalized) had not resolved and ERYTHRASMA (Erythrasma) outcome was unknown.            This case was linked to MOD-2021-228244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow-up received on 16-Jul-2021 Contain added events information on patient demographics, patient history, concomitant medications, added treatment and outcome of not recovered. kindly assess as reported in SD.
Patient only got the the adjuvant; Patient only got the the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporter's comment: The reporter was the patient's son who stated that his mother got her first Shingrix vaccine. However, the nurse just let him know that she did not reconstituted the vaccine and so the patient only got the adjuvant.  The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the patient had received only the adjuvant part, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
fever; chills; headache; myalgias; fatigue; This is a spontaneous report received from a contactable Physician. A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient had no medical history and concomitant medications were not reported. Family history included. On 03Mar2021, patient he woke up with fevers and chills. He then experienced headache, myalgias and fatigue which prevented him from going to work that day. He had never tested positive for COVID-19 or had a known contact with a COVID-19 positive patient since the start of the pandemic. Family history was positive for a paternal grandmother who had congestive heart failure and coronary artery disease but was diagnosed after the age of 50. He denies any alcohol, drug or smoking use. Patient underwent lab test which included Troponin, Result: 9.110, Units: ng/Ml (Norm Low:0 Norm High:0.034) on 07Mar2021 comment: initial troponin value of 4, peaked at 9.1; ESR Result:23 Units: mm/HR (Norm Low:0 Norm High:10) on 08Mar2021 comment: initial troponin value of 4, peaked at 9.1; CBC on 07Mar2021, Result: within normal limit Units: mm/HR (Norm Low:0) Comment: no increased eosinophils; Drug screen on 07Mar2021, Result: Negative (Norm Low:0); CRP on 08Mar2021, result:5.6 (Norm Low:1.0); Cardiac catheterization result: normal, Date: 08Mar2021, Comment: normal coronary arteries, focal area of inferior basal hypokinesis with normal ejection. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; sick all over, rash, swelling at site; sore arm & neck;
Sunday evening patient noticed raised rash on right arm and right upper abd area. No itching, no pain.  At time of this report, rash is resolving on it's own.  No treatment was administered.
The pt had to go to the ER. He was violently ill. After the immunization, head growth and weight growth stopped for a month. He was subsequently hospitalized for 2 weeks.
Pt was given vaccines - left office. On way home increased nasal secretions/coughing. Approx. 30 min later father noticed hives on her trunk/face - extremities. No wheezing. Brought to office - BENADRYL given - observed. Happy - talkative.
About 3 hours after the shot I started feeling tired, my eyes felt heavy. Shortly after I was shivering, my muscles were having spasms, I had a 100.7 fever, body aches, headache.  My heart was beating at about 105/minute while resting. I was nauseated and dizzy. Tried to walk to the kitchen and nearly fainted, couldn't keep my eyes open even if awake because of the pain. Lasted about 36 hours. It was scary and severe. Now I'm at the 48 hour mark and I feel much better, have a headache and feel sore, but all other symptoms are gone.
pt recv vax & devel raised, white local rxn w/red streaks towards the elbow;
Pt received Flu and pneumo in same arm 10/31/14 pt states that over weekend a circular welt formed on her (L) arm that is now hot, erythematous, raised and painful. She states that it is now itching.
A report has been received from a pharmacist concerning an 8 year old male subject, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 17-Nov-2014. It was reported that stopper came off or wasn't on the FLUMIST Quadrivalent and it went all in one nostril which started on 17-Nov-2014. The outcome of the event of stopper came off or wasn't on the FLUMIST Quadrivalent and it went all in one nostril is unknown. The report was considered to be non-serious. Corrected report 20-Oct-2015: Key ingredient updated. Initial unit updated.
Tested for positive for COVID after a shot in May; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested for positive for COVID after a shot in May) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced COVID-19 (Tested for positive for COVID after a shot in May). At the time of the report, COVID-19 (Tested for positive for COVID after a shot in May) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive test results on the 11th..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient had the IV Inoculant on the 13th.  Company comment: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of an unknown dose of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.; Sender's Comments: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of an unknown dose of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.
Fever, mucsle and joint pain, injection site swelling and soreness, headache, all lasting 2days.
Wife states shorts of breath, occ cough started mid February gradual onset and worsened went to clinic Feb 28th saw FNP, d dimer elevated, hospitalized many small clots in both lungs
Patient mother reports emesis 9:15 pm 08/08/2006, 10 pm note swelling on right thigh injection site with redness, temperature to 103 degrees, gave MOTRIN.  Called clinic in am, seen 1 pm 08/09/2006 temperature 101 degrees, redness, tenderness right leg.  Instructed mother ice to leg, Ibuprofen for fever and tenderness.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-OCT-2012 21:01, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.