chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; severe chest/ back muscle pain so intense; rib joint pain so intense; Couldn't take deep breaths; severe chest/ back muscle pain so intense; Joint body aches; Low grade fever 100.5; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense) and ARTHRALGIA (Joint body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension in March 2000, Gout in 2014 and Flu. Concurrent medical conditions included Drug allergy (Allergic to Ibuprofen (High doses/long duration only)). Concomitant products included FOSINOPRIL for Blood pressure high, ALLOPURINOL for Gout, ASPIRIN [ACETYLSALICYLIC ACID] for Heart injury NOS, MECOBALAMIN (B12 [MECOBALAMIN]), VITAMIN D3, MENAQUINONE-7 (K2) and FISH OIL from 02-Feb-2020 to an unknown date for an unknown indication.    On 03-Mar-2021 at 12:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 2:00 PM, the patient experienced CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), PYREXIA (Low grade fever 100.5) and CHILLS (Chills). 10-Mar-2021 at 2:00 PM, the patient experienced BACK PAIN (severe chest/ back muscle pain so intense). 10-Mar-2021 at 2:00 PM, the patient experienced ARTHRALGIA (Joint body aches). On an unknown date, the patient experienced FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Mar-2021, CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense), ARTHRALGIA (Joint body aches), PYREXIA (Low grade fever 100.5), CHILLS (Chills) and FATIGUE (Very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100.5 (High) 100.5; low grade fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Added medical history and treatment drug. Event description and outcomes were changed to recovered/resolved.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Mild, Additional Details: MILD SWELLING AND RED RASH ON FACE SINCE FRIDAY AFTER RECEIVING VACCINATION
it was given intradermally; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29-NOV-2024) for prophylaxis.   On 13-MAY-2023, the patient received Boostrix (intradermal). On 13-MAY-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: it was given intradermally). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 A medical assistant reported that a female patient received a dose of Boostrix that was given intradermally. The health care professionals (HCP) said it was given intradermally like a (tuberculosis) TB test. The vaccine administration facility was the same as primary reporter. The patient received Boostrix intradermally, which led to intramuscular formulation administered by other route. The reporter consented to follow-up via email.
Pt was given Moderna dose in December.  Was under the impression because of the time lapse that she had to restart the series and wanted to use Pfizer
symptom onset about 11/2/21: include fever, cough, shortness of breath, chills, myalgias, nausea., hypoxia.  Possible exposure prior week at a nursing home rehab center
I recieved my second dose of the Moderna vaccine on 3/6/21 at 3pm and by 9am on 3/7/21 I had a fever of 101.6 and it would spike up to 102.6 going up and down over the next 2 days. I experienced a high fever that only decreased to a low fever of 100.5 with ibuprofen and cool baths and cold fluids for two days. The injection site was swollen and painful for 3 days just like the first vaccine, but the fever and full body aches accompanied by once of the worst light sensitive headache I have ever experienced lasted for 2 days. The 3rd day was interesting, my fever broke and my lower back now ached very bad and I was weak to stand. The most interesting thing that happened on the third day was a full badly rash that looked and felt like a full body sunburn. My fever had broken, but my skin was bright red and radiated heat of 101.5, but my head temp read normal 98.6 The red sunburn skin cut off dramatically at my wrists. I took pictures because it was so bizarre looking. By Wednesday morning the rash/sunburn was almost 70% gone and I was starting to feel like a normal human being again.  I would like to note that I had a very mild fever 99.9 with my first vaccine shot and my arm was very sore and swollen for 3 days. I did also have a mild fever rash on my belly, back & forearms I would also like to say this was the sickest I have been in over 5+ years ( my second dose) it was no joke! Thank god for my husband taking care of me, I don?t know what I would have done if I was alone.
My lips began to swell 30mins after getting the vaccine.; My left arm feeling heavy and strange; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer (patient) reported for herself that:  A 55-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot unknown reason=Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 20Jul2021 12:00 as dose 1, single for COVID-19 immunization. Medical history included   from an unknown date and unknown if ongoing. Patient don't have known allergies. The patient receives other medications within 2 weeks of vaccination: Aleve, melatonin, multivitamin, Allerclear. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported; loratadine (ALLERCLEAR) taken for an unspecified indication, start and stop date were not reported. On Jul2021 at 12:30 PM patient lips began to swell 30mins after getting the vaccine, left arm feeling heavy and strange. Patient didn't received treatment for the events. The clinical outcome of the event was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Vaccine rec'd on 01/21/21, on 1/23/21, awoke with right and left arm pain with swelling and pain at injection site.
4/1 at 10PM started aching. Took tylenol and went to bed. by midnight she was feeling worse. She had chills and achiness and shivering. By midnight she had chills and aching and shivering. By 4/2 0600 she took ibuprofen but had a fever, aching and chills that were getting worse. By 4/3 she had vomiting and diarrhea. She finally felt better 4/5 but remained very tired. She finally felt back to normal on 4/9/2021.
Presented w chief c/o fall, O2 dependent d/t chronic resp failure; COVID-19+; tx w/remdesivir, abx, steroids, zinc, O2; dc to SNF.
My arm muscles and leg muscles was aching all over with sharp pain. I went to my doctor. They did blood work, result they my lymph nodes was high. She is also referred my to a specialist.
Received 2 vaccines in upper arms Fri 11/14/05. Sunday 11/16/05 right arm swelled from shoulder to elbow, with demarcation, deep red color, warm to touch, significant pain.
Pt vaccinated with Pneumovax 23 experienced pain, redness & tenderness at the site of the inject which resulted in limping.
Patient stated she is having a :"panic attack"  post vaccination. BP 130/82 HR 64 R 22; Patient states she has a history of panic attack since childhood age. 1250pm 130/80 "Boyfriend picked patient up:" no distress noted.
Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as DRAVET syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with DRAVET syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09599, and -09600. A four-month-old patient received PERTUSSIS VACCINE (manufacturer unknown, lot number, route site and date of administration not reported) and less than 12 hours after vaccination, developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic and partial seizures, which were intractable to multiple medication trials. The patient had mild expressive speech delay. Initial brain brain MRI results revealed an unspecified abnormality which later resolved. At2 year of age, patient was diagnosed with DRAVET syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed missense mutation (A1171C, Thr391Pro) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis were normal. Outcome was not recovered. Documents held by sender: None.
Vaccine administered 5/13/15-reported itchy, sore rash on lower abdomen (5/15/15 received call from pt's granddaughter 9:25 am) ("Rash" looks like a large bug bite, (round) and greater than size of quarter. Very itchy.
A ~2 inch circle rash/spot that is pink/red in color formed at the injection site 7 days after receiving the vaccine. Some itching occurred but it has subsided. There is no pain at the spot. This is the first adverse reaction since  since arm pain 1 day after receiving the vaccine.
Itching on left arm, elbow down to wrist on both arms had hives, took Benadryl and hives cleared.
This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Patient started itching, then having trouble breathing about 20 minutes after getting shots.  She was seen in our Urgent CAre which is in the same building.  She was given a breathing treatment Benadryl 25mg IV,and Decadron 4mg IV.  She was then transported by ambulance to Medical Center.
Case number PHEH2014US0249917, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 57-year-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 11 Nov 2014. The nurse reported that 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 between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Numbness on right side of forehead/skull that radiated and pulsed down face. This lasted for over 48 hours.
Feverish, headache, earache starting in one ear then becoming in both ears, extreme fatigue, sinus pain on right side, right tonsils pain, right cervical lymph nodes pain, nausea. All the above symptoms started  24 hours after injection and currently at 42 hours slowly subsiding.  Left arm injection site swelling and redness. Started 12 hours after injection and continues to get bigger and more painful now at 42 hours post injection.
COVID Arm.  Approximately 5 inch long and 3.5 wide red rash around injection site.   Rash is itchy, tender and feels warm. Area feels tight too.
Patient presented to the pharmacy concerned... had decent erythema and demarcations  all along his deltoid and lower arm. Also had a lump from injection site still present one 1 week later. Explained to let us know if does not improve.
The day after I received the vaccine, I felt feverish and fatigue. It knocked me out. The symptoms were certainly gone within 24 to 48 hours. On 6/14/2022 I had blood work done. My liver enzymes were high, my A1C was up, and my kidney numbers were high.  My endocrinologist suggested I go to a gastroenterologist, liver specialist, to check my liver enzyme. I had blood work done by that specialist and the results were fine. The enzymes had gone back to normal at that point. My kidney functions, I just saw my nephrologist, and he tell me that my kidneys seem to be stable. High but stable. next week I will go see my endocrinologist for my sugar, but that is to be determined. At the beginning of 11/3/2022. I will be going to my urologist, and he will let me know if I need a biopsy. I had bladder cancerous tumor removed 25 years ago in 5/2001 and in 12/2001, I had a second bladder tumor removed. Since then, I had no problems with my bladder.  This was the first time the urologist looked inside my bladder and was unsure what he saw. I decided to wait 90 days check it again. As of a week ago, my liver enzymes and my kidney numbers were getting back to a better level. Next week, I will find out if my sugar levels are at a better level.
pt recv 2 doses of vax 17FEB96 & 17APR96 & 28JUN96 lab eval revealed IgG less than 0.7 & the pt exp a lack of seroconversion;
On 08/19/04, mother telephoned with complaints of red, swollen right thigh- "mood not normal", but denies lethargy, but irritable. Varivax given 08/06/04, advised to observe. Give Tylenol or Motrin per directions, over the counter Benadryl as well. Call if worsening or no improvement.
immediately after vaccination the injection site became red and swollen. patient advised to wait in store for 15 minutes. after 15minutes the site decreased in swelling but still remained very red and blotchy. patient stated she felt fine and would continue to watch site. advised tylenol and to continue to watch.
Patient received a vaccine that was 10 days beyond its use-by date (3/6/23). (mislabeled 4/6/2023)  Per physician, no adverse effects noted
I have a positive pregnancy test on 12/26. I went to ER for bleeding on 12/28. On 1/7 went to pregnancy center for intermittent bleeding and 1/12. It might be potential of  more  bleeding so far haven't had any bleeding pst week. (estimated date of delivery 9/7/2021)
patient was administered covid pfizer bivalent booster vaccine and within minutes she had trouble breathing and holding her throat. pharmacist administered epinephrine and 911 was contacted. patient immediately improved after administration, her throat felt better and breathing improved. local county sheriff was in close proximity to pharmacy and came in while awaiting local ems and police to arrive. pt was stable and was assessed by local ems. she had elevated blood pressure due to epinephrine. mother opted not to transport to ER by ems. Patient and mother left the pharmacy about 7pm. Pharmacist followed up with parent next day 1/6 about 930am and mother stated she did take daughter local ER for further evaluation where she was given rx for benadryl, prednisone, and epinephrine
The pt experienced a sore injection site, shivering and nausea. The pt couldn't get warm.
Episode of syncope after receiving the covid vaccine. Secondary injury to back of head after falling out of chair.  3:05 PM  Vital Signs: BP 118/62 HR 92 Resp 18 O2Sat 98  Skin Signs: Warm and dry  Initial Treatment: Initial impression: altered mental status, shallow breathing, pupils Perla. Patient regained consciousness and was able to respond to questions. Patient was placed in a wheel chair and taken to triage area. Vitals taken.  3:20 PM  Vitals: BP 116/82 HR 82 Resp 16 O2Sat 98  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Denies nausea. AOx1 No longer feeling 'shaky'. Very sight swelling at the site of head injury. Ice pack in place.  3:35 PM Vitals: BP 116/66 HR 78 Resp 16 O2Sat 99  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Home with mother with CHI instructions.
12 days of severe fatigue 5 days of headache 3 days of polyarthralgia 4-5 days of shortness of breath
skin sensitivity; She was not able to sleep the past two nights; due to the itching/body-wide itching; body aches; fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose and developed back pain, refer case US2023098120). Concurrent medical conditions included celiac disease.   On 12-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 13-JUL-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: fever) and headache (Verbatim: headache). On 15-JUL-2023, the patient experienced sensitive skin (Verbatim: skin sensitivity), insomnia (Verbatim: She was not able to sleep the past two nights) and pruritus (Verbatim: due to the itching/body-wide itching). The patient was treated with fexofenadine hydrochloride (Allegra). Rechallenge with Shingrix was positive. On 14-JUL-2023, the outcome of the general body pain, fever and headache were resolved (duration 1 day). The outcome of the sensitive skin, insomnia and pruritus were not resolved.   It was unknown if the reporter considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.     It was unknown if the company considered the sensitive skin, insomnia, pruritus, general body pain, fever and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023098120   Additional Information: GSK receipt date: 17-Jul-2023 The patient received her second Shingrix dose and next day she again had fever, headache and body aches.  3 days after the vaccination, the patient experienced body-wide itching and skin sensitivity.  Water, heat, sweating and any touch triggers the intense itching.  The patient was not able to sleep the past two nights due to the itching and she spoke with the on-call physician over the weekend (15th July 2023 or 16th July 2023) and was told to take Allegra.  The Allegra had not relieved the itching and did not had a rash.  Nothing else was reported. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023098120:same patient, first dose
Date of Admission: 10/24/2022   Date of Discharge: 10/27/2022   Admission Diagnosis: STEMI (ST elevation myocardial infarction) Myocardial infarction acute     Hospital Principal Problem (Discharge Diagnoses): Acute ST elevation myocardial infarction (STEMI) of inferior wall
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 17-May-2020 and the estimated date of delivery was 21-Feb-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.  The patient had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.
She received the Pfizer Bivalent inoculation on 11/29/2022, and at that time, was clinically stable with her acute issues with no recent exacerbations.   By 12/01/2022, she with productive cough, hoarseness, wheezing with shortness of breath.  this progressed over the next several days.  negative CXR, yet increasing respiratory distress/cough and edema.  she did not respond with any resolution of symptoms with steroids, diuretics, antibiotics.  she progressive worsening until sent to hospital on 12/28/2022 where had CXR with multifocal pneumonia and she expired on 12/29/2022.
Patient came in to pharmacy to pick up prescriptions. She complained of a flu shot given to her previously on 11/19/15 (FLUZONE HD). She has previously complained to another pharmacy but never complained/reported to our pharmacy personnel previously. Pt is requesting compensation - to see a doctor for flu shot pain.