chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense and comprehensive body ache not remedied by otc pain relievers or ice, headache, low grade fever
BODY ACHES; TIRED; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had b+ blood type. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced body aches. On 04-APR-2021, the subject experienced tired. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tired on 04-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210451256, 20210451243, 20210451285 and 20210452044.
Swelling to wrist, down to hand and unable to make a fist. No redness or fever. Referred to PMD. Itching at injection site.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated wit improperly stored doses of ROTATEQ, orally, lot #: L0000458, expiration date on 13-JUL-2015 (dose and anatomical location were not reported, which were stored in a temperature of 31F during 45 days. No previous temperature excursions was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, lot #: L041248, expiration date: 27-JAN-2016, which were exposed with the same conditions. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reported coming from the same source. Additional information has been requested.
Approx. 14 hours after receiving the 1st part of Covid vaccine my arm became so sore I couldn't move it. It was sore from my neck down to just below my elbow. I began having chills and a low grade temp shortly after that. by 0130, I was dizzy, experiencing diarrhea, with episodes of diaphoresis, and acute nausea. I felt that I had some postural hypotension, was very pale and every time I would get up to walk I felt like I was going to end up on the ground. I remained in bed for approx. 16 hours before I felt like I comfortable even getting up and going to restroom. I still have intermittent dizziness, with syncope to this date.  I had to leave work early as well as calling in sick for the next shift.
Left facial paralysis with onset 11/16/08.  Diagnosed with Bell's palsy on 11/17/08. HEENT: Fundi nl. TM's and ears clear. no vessicles. OP clear. nares patent.  neuro:      A & O; CN 2-12 nl except for 7th cranial nerve: L forehead weak,  can't raise L eyebrow, can't close L eye; L side of mouth drooping; sensation to  light touch nl all ext; strength 5/5 all ext; muscle tone and bulk nl.  coordination nl to past point, rapid alternating movements; gait nl; DTR's symmetric and non-pathologic all extremities; romberg negative; babinski negative; no clonus.
This came on gradually over a period of about 5 hours:  headache, aching in the joints, abdominal cramping, lethargy.
Child received vaccines on 9-24-07. Child was very fussy and crying after vaccines. Child was able to take Motrin per MD's orders and didn't need to be seen.
Swelling in the neck and shoulder area, particularly under both arms (lymph nodes). Headaches - severe swelling of both ankles. Blood work being done as well as CAT Scan of affected area - neck - chest - underarms, etc.
she had been feeling a lot of pain in left armpit/armpit hurt with any movement; felt a large lump in armpit; she was constantly feeling hot and then cold; felt worse; Administration date: 04Oct2021; Dose number: 3; Administration date: 04Oct2021; Dose number: 3; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old non pregnant female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 04Oct2021 at 08:45 (at age of 34-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included asthma, gastrooesophageal reflux disease, irritable bowel syndrome, fibromyalgia, eczema, seasonal allergy, dust allergy, allergy to animal dander. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient was not tested for COVID-19. Concomitant medications (in two weeks) included montelukast was taken for unknown indication, start and stop date were not reported fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) was taken for unknown indication, start and stop date were not reported; dupilumab (DUPIXENT) was taken for unknown indication, start and stop date were not reported; dicyclomine was taken for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262) via an unspecified route of administration, administered in left arm on 30Jan2021 (at age of 34-year-old) as dose 1, single and the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201) via an unspecified route of administration, administered in left arm on 17Feb2021 (at age of 34-year-old) as dose 2, single for covid-19 immunization. On 04Oct2021 at 13:00, the patient experienced she had been feeling a lot of pain in left armpit/armpit hurt with any movement, felt a large lump in armpit, she was constantly feeling hot and then cold, felt worse. Patient administration date: 04Oct2021, dose number: 3. The patient reported that she had been feeling a lot of pain in her left armpit. This morning she felt a large lump in armpit. Over the past 3 days, she was constantly feeling hot and then cold, but her temperature was 97.7. The lump in armpit hurt with any movement, did not get better with a heating pad, and she had been taking Ibuprofen to help with the pain. She had been trying to move her arm around to see if that helped, but it was just made her feel worse as the day progressed. The patient underwent lab tests and procedures which included body temperature: 97.7 on 04Oct2021 over the past 3 days, she was constantly feeling hot and then cold, but my temperature was 97.7. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient received vaccines around 1 pm. His wife called around 6:45 pm to report that patient was having chills, and tingling/ numbness in his hand. He also complained about nausea.  All these symptoms lasted about an hour.  Patient did not report taking any medications for the symptoms.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent condition, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) Lot # K010797 expiry 04-FEB-2016 (dose, frequency, route of administration and indication were not provided). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Puffy eyes and face, swollen, but no other symptoms. Vaccinated at 4;45 pm and had mild inflammation 3 hours later, woke up today at 1pm with eyes and face completely swollen
This baby was observed to be limp. The parent were unable to wake the baby up. He had upward rolling of the eyeballs. No fever. Admitted to the hospital. Sepsis R/O, EEG, CT head - normal.
Flare up dermatitis atopic; Itching; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021, (at the age of 43-year-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization; dupilumab (DUPIXENT, pre-filled pen, strength: unknown), subcutaneous from 07Apr2021 (Batch/Lot Number: 0F025A; Expiration Date: 31Oct2022) to 07Apr2021, at 600 mg, 1x/day, subcutaneous from 2021 (Batch/Lot Number: 0F025A; Expiration Date: 31Oct2022) and ongoing, at 300 mg QOW for dermatitis atopic. It was reported loading dose of 600 mg 1X (once) and 300mg SQ every other week as maintenance dose. Last dose of dupilumab was this morning 15Jun2021, and her other dose was taken on 01Jun2021. It was not the first time that patient had used the product. The patient medical history included dermatitis atopic and concomitant medications were not reported. On 19May2021, the patient experienced flare up dermatitis atopic and itching. The patient was treated with prednisone for Dermatitis atopic. The clinical outcome of the event dermatitis atopic was recovered on 10Jun2021 whereas the event itching outcome was unknown.  Follow-up activities closed. Batch/lot number not available.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORUMLA.
severe chills and fever... 103 degrees. racing heart, Nausea, vomiting, severe frontal headache, severe joint pain, especially spinal pain, back and neck pain, severe hip pain, and a right lateral side of ankle that still feels sprained 2 1/2 days later.  I have not been in to see a doctor yet because I am finally recovering from the fever.
I got very loud tinnitus 3 hours of the vaccine. I still don't feel well feels like inflammation. I have aches in my hands and knees. Symptoms worsen after the second dose of the vaccine.
day p/receiving the vax pt woke up feeling dizzy, light-headed & queasy; also noted black stools;
mom called to report pt exp inconsolable crying, high pitched began approx 10PM p/vax; lasting all day
Patient presented 2 days post vaccine with swelling in arm and elbow region. Patient saw a doctor and received a prednisone order to help. There was no bruising or adverse signs of vaccine not being administered correctly. It was very evident that it was a reaction to the shot itself. Patient had no reactions to prevnar 13 vaccine given a year ago.
On Saturday, July 2nd, I woke up at 3:37AM I took my temp and it was 99.3. All day Saturday and Sunday I didn't have a bowel movement. I had a headache and took TYLENOL to relieve. I had a bowel movement three days later. The first one was normal and the second one was like diarrhea. I tested myself on July 5th, with a home COVID-19 and it was positive. My normal temp is 97.9. As of today, July 6th, I feel fine. I no longer have dizziness, aches, or lack of appetite or fever. Also, on July 5th, I saw my doctor and he recommended I take MUCINEX DM.
Fever to 102, fatigue, HA, malaise, dizziness,  injection site tenderness
Patient presented for COVID booster. Received Moderna 0.25ml IM which was not approved for patients under the age of 18 at that time. Patient waited 15 minutes with no complications.
Started getting itch and notice hives on the trunk of the body and back, face swelling up. No difficulty breathing.
Red inflammation/rash around the  injection site, itching at injunction site; tenderness at injection site. Pain has persisted. Lymph node (possible) under arm is painful.
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe  (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes.  March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
HA, dizziness, difficulty breathing body ache, feet/hands tingle treat symptomatic, no abnormal lab
pt recv vax & exp dizziness & low fever,felt hot,c/o unaware of speaking to babysitter & did not remember a conversation had an out of body feeling & felt sick to stomach;
Inflamed; Has a lump on it, the size of a small egg; Very itchy; Real red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Heart rate irregular. Concomitant products included ATENOLOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red). On 06-Feb-2021, VACCINATION SITE MASS (Has a lump on it, the size of a small egg) and VACCINATION SITE ERYTHEMA (Real red) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Very itchy) outcome was unknown.        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.   Treatment information was not provided.
Pain all over her right arm (not the one that was injected); Cramps on both legs; Not very clear-headed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain all over her right arm (not the one that was injected)), MUSCLE SPASMS (Cramps on both legs) and CONFUSIONAL STATE (Not very clear-headed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B2119) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain all over her right arm (not the one that was injected)), MUSCLE SPASMS (Cramps on both legs) and CONFUSIONAL STATE (Not very clear-headed). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 13-Apr-2021, PAIN IN EXTREMITY (Pain all over her right arm (not the one that was injected)), MUSCLE SPASMS (Cramps on both legs) and CONFUSIONAL STATE (Not very clear-headed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up contains TCR document with No New Information
Patient is a 65 year old female with a history of AFIB (on Eliquis), COPD, chronic airflow obstruction, a MI, polycystic kidney disease, renal disease, a hysterectomy, a hernia repair, a back surgery, and a renal transplant who presents to the ED with a chief complaint of difficulty breathing that began about 3 days ago. Patient explains that she typically only wears supplemental oxygen at night via CPAP, although about 3 days ago her difficulty breathing and shortness of breath began worsening. She additionally has been experiencing a cough with "clear" phlegm production, as well as decreased oral intake and oliguria. Her PCP recommended that she double her dose of Bumex for the last 3 days, although she feels she has had no improvement with urine output. This morning, she woke up after wearing her CPAP machine at night and noted oxygen saturation values of 77%. Patient additionally complains of nausea, vomiting, and diarrhea for a ?few? days. Due to concerns for her symptoms, a call to EMS was placed to be have patient brought to the ED for evaluation today. Patient adds that she follows with Dr. in pulmonology, and she is compliant with taking her Eliquis. She believes she has been on steroids recently, although she is unsure. Patient denies fever or chills. The patient is a former smoker and has no further complaints at this time.
Information has been received from a physician concerning his approximately 23 year old daughter with drug reaction to SEPTRA, allergy to peanut and a history of familial Mediterranean fever who on an unspecified date was vaccinated with the second dose of GARDASIL (route and lot# not reported). Concomitant therapy included ZYRTEC and FLONASE. The patient received the first dose of GARDASIL "here" and the second dose at "student health". This patient did not have any problem after the first dose of GARDASIL. "Next day after the 2nd dose", the patient experienced severe arm pain and swelling for 2 weeks. "2 weeks after 2nd dose of GARDASIL" the patient recovered from severe arm pain and swelling. No diagnostic laboratory tests were performed. Additional information has been requested.
This spontaneous report was received from a physician assistant referring to a 14 year old patient of unknown gender. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On 02-JUN-2015, the patient received the first dose in the vaccine series of GARDASIL (also reported as GARDASIL 9) (lot# K001631, expiration date: 06-NOV-2016) (anatomical location, dose, route and frequency were unspecified). Then, on 15-JUN-2015, they received the second dose of GARDASIL (also reported as GARDASIL 9) (lot# K023432, expiration date: 18-JUN-2016) (anatomical location, dose, route and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Cerebral Vascular Accident; Shingles; Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. On or about 26-JUN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered inability to walk, weakness in left side, fatigue, no control of left side and slurred speech and he was diagnosed with a cerebral vascular accident; patient suffered pain in the back and noted visible lesions scabbing and sensitivity to touch and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident and herpes zoster was unknown. The reporter considered cerebrovascular accident and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of cerebrovascular accident  was determined to be medically significant.
A non-serious spontaneous report of cold has been received from a MedImmune representative concerning a 36-month-old female subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  The patient received FLUMIST on 25-Nov-2009.  On 28-Nov-2009, the patient experienced cold and "was placed on antibiotics."  The patient was not hospitalized.  The outcome of the event was recovering.
Pain; Stiffness; Fatigue; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a week. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form once a week. In January 2021, the patient experienced ASTHENIA (Weakness) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness). In 2021, ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products reported.  No treatment products reported.  The reporter's causality for the event(s) of WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in 2021, WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in 2021 and PAIN was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-620709.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Live follow up received on 14-Apr-2022 included significant information received. updated patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The event of "STIFFNESS" was added.
Both (L) and (R) raised small red bumps/itchy (no fever/no other symptoms).
Patient was 17 years of age at time of vaccination. Vaccine is indicated for 18 years and older. Patient was called with no answer and no voicemail setup. Patient has not returned call.
Nausea and Vomiting and Diarrhea within one hour of vaccine administration. >5 episodes of vomiting and 6-7 episodes of diarrhea.
24 hours after 1st PCV, baby's thigh feels hard and small red area around injection site. Baby extremely irritable and drowsy 24 hours after as well.
SWOLLEN, INFLAMMED LEG AT INJECTION SITE. TREATMENT WAS KEFLEX & PREDNISONE. OUTCOME IS PENDING.
After about 7 hours after injection, resident came down with nausea/vomiting/diarrhea and still has 21 hours later.