chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stabbing pains in leg muscles and hip and knee joints; stabbing pains in leg muscles and hip and knee joints; upset stomach; chills; headache; sore shoulder; tired; queasy; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2019, 1 days after receiving Shingrix, the patient experienced shoulder pain, tiredness and queasy. On 24th March 2019, the patient experienced muscle pain, joint pain, upset stomach, chills and headache. On an unknown date, the outcome of the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache were recovered/resolved.   It was unknown if the reporter considered the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache to be related to Shingrix.  Additional information was reported as below: On the next day, the patient's shoulder was sore and he felt tired and queasy.  The symptoms lasted for about 3 days before he started feeling better.  4 days after receiving Shingrix, the patient suddenly started having stabbing pains in his leg muscles and hip and knee joints. The pain would come in wave, getting stronger the ebbing again and then returning again sometime later. The muscle and joint pains occurred only below his waist.  He would also have waves of upset stomach, chills and headache, though these were not as severe as the muscle and joint pains.  He had been feeling better for the past day and a half, so he hopes he was past these symptoms. The patient consented to follow up but declined to provide his address.
Red rash on front legs and arm lasted 24 hours; Itchy skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 14:30 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Red rash on front legs and arm lasted 24 hours"; PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "Itchy skin".  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
DEATHLY ILL FOR A WEEK; EVERYTHING; RAN A FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced deathly ill for a week, ran a fever, and everything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill for a week, and the outcome of ran a fever and everything was not reported. This report was non-serious.
No adverse reaction-no problems to this point, child under 2 yr. given FLUMIST instead of a 0.25 cc injection at a H1N1 mass vaccination clinic.
chest pain, shortness of breath, fatigue, malaise, headache that occurred the evening after vaccine was given
Painful feet, weak legs, burning teeth, painful temples, insomnia, progressing can?t walk or stand long without painful legs feet with spasms weakness, unbalanced, high d Dimer, dystonia like reaction unknown in sept. Hospitalized twice following august in September and November currently. Disabled fully trying to get answers.
Pt recvd vax 10FEB89 & on 15FEB89 exp a generalized rash w/mild pruritus, localized primarily on the chest, arms & thighs; 22FEB89 presented to the MD office & rash was described as a fine macul-papular dermatitis; rash had mild itch;
did not get second shot; weak; hands are swollen; hands are swollen, numb and tingling; hands are swollen, numb and tingling; every bone in my body felt stiff; I couldn't move and I had to throw myself from my body to get up and go to the bathroom; tired; significant whole body pain; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get second shot), ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling) and PARAESTHESIA (hands are swollen, numb and tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neutropenia and COVID-19 pneumonia (for 2.5 months, approximately 8-9 months ago.). Concurrent medical conditions included Asthma and Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second shot). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not get second shot) had resolved. At the time of the report, ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medicines for asthma. She has talked to her PCP by video visit for her symptoms who referred her to a "bone specialist." Additionally he recommended that she should not receive the second dose of the vaccine. She had been to the emergency room for her symptoms twice. The first time they provided her narcos for her pain which provided relief for about 30 minutes before returning again. The ER doctors also said that her symptoms were due to an arthritis flare up. She said that her white blood cells were normal at those visits. Her last ER visit was on 15-APR-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: No new information reported On 21-Jul-2021: No new information reported
I had my vaccination on 09/16/2022. I am unsure of exact dates but I was diagnosed with Mixed Connective Tissue Disorder. I was diagnosed earlier in 07/2022 but the main diagnoses were in 11/2022 with a Rheumatologist. I am being with specialty care from 04/2023 for additional blood tests.
01/02/22 presents to EC ED for "confusion, post fall, progressive deterioration". PMHx of "Hypertension, CKD, diabetes mellitus type 2, dementia"
Pt developed HA that evening.  Severe-went to sleep.  Next day while exercising developed extreme fatigue, muscle weakness, SOB, blurred vision & dizziness.  Symptoms are resolving today (7/30/08).  Pt is a collegiate athlete.
Case number PHEH2014US023267, is an initial spontaneous report from a pharmacist received on 18 Nov 2014. This report refers to a 43-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1413701) intramuscularly on 05 Nov 2014 On an unknown date, after vaccination, she experienced pain at the injection site. Outcome of the event was unknown. Seriousness and causality of the event was not reported.
Patient received - BOOSTRIX and TYPHIM in left arm then HAVRIX in right arm. Pt. fainted, then convulsed. 911 was called, by the time 911 was on line patient had stopped convulsing and woken up. He was dizzy and nauseated. After 30 mins. patient felt fine. Refused paramedic help and walked out of pharmacy.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
localized erythema, warmth 2cmx6cm @ site rt thigh; fever to 102 & significant irritability but can be consoled by mom;
turned white, almost gray, x 1hr then was better, t100, irritable-info relayed to MD by phone 4hrs p/vax
On March 18, 21.   pts. left fingers were blue. she was diagnosed with blood clots. Ends of fingers died, lack of blood flow. They have been amputated. She is also swollen.
On the day of the shot, arm soreness.  The following day, fever, chills, and tiredness.  Just a feeling of "not feeling well."
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/12/2021 and 3/5/2021. Presented to ED on 9/5/2021 with complaints of generalized weakness, cough, body aches, diarrhea, as well as subjective fever and chills. Weakness has been progressing over 1 week. Patient treated with dexamethasone, remdesivir, ceftriaxone, azithromycin. Increasing O2 needs on 9/8. On 9/15 patients condition deteriorated, and using high flow O2 80% 50 L.  Patient expired on 9/16/2021.
15:25 RN informs supervisor that she has vaccinated a pediatric patient, patient, early in her series. Original series scheduled for 1/3/22 and 1/24/22. 1/3/22 clinic cancelled due to inclement weather. Patient has no adverse reaction, and patient sitting comfortably with mother in observation area, no distress noted. RN. talks to supervisor and RN about incident and what to do following up. No new vaccination needed in series, no further medical treatment is needed. 15:30 RN talks to mother about incident. RN instructs mother to take v-safe and to monitor patient for adverse reaction. Reactions explained that could be/not limited to headache, fever, body ache, chills, and decreased PO intake. Mother seems un-phased by interaction and explains that it is because a previous clinic was cancelled and she still had and appointment for today.  Multiple check points addressed due and clerical personnel questioned about checking points. Mother informed to report any side effects with v-safe, to contact her pediatrician if any medical concerns arise. Mother expresses appreciation of transparency. RN addressed about importance of medication rights, and how to identify timing with vaccination card and in the computer. Will follow up with management regarding further education.
cOugh; Fever; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, COUGH (cOugh), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  Patient  took a rapid test and tested positive.   Reporter did not allow further contact
I received my shot on Friday. Saturday I woke up with a temp and feeling terrible, very weak, nauseated, couldn't eat. This lasted until Saturday evening. Sunday I developed a rash near the injection site.  By Wednesday it was getting larger and went from a small patch to covering my whole upper arm from my shoulder to my elbow completely around my arm by Thursday when I saw my Dr. A cortizone cream was ordered. On Friday the cream had helped and by Monday the rash was gone.
Thrombotic CVA of L hemisphere and spleen.  CVA occurred overnight and was complete when patient found. Therefore, no treatment.  Result R side paresis arm and leg and aphasia/apraxia.
After second vaccine dose on 1/8/2021, I felt fatigue and muscle aches on 1/9/21 in the afternoon. I felt normal on Sunday and throughout the week. Then, 1-14-21 starting around 8am, I developed GI symptoms, stomach cramping, nausea, and also light-headed and muscle aches. I left work and at home developed a headache and fever of 100.8 F which reduced to 100.2 F with ibuprofen. The fever went away over night so I came to work the next day 1/15/21 and continue to have stomach cramping and slight nausea and was concerned about the fever the day before so that is when I called employee health.
Mild fatigue/malaise, dull headache (22+ hours...), light nausea with onset of headache, .  Other than hydration and caffeinated beverages, I may try acetaminophen or aspirin.  I do not know if the booster is responsible.  I also was using a bleach cleaner when the headache appeared (not a lot...).    The question on the next page asks about vaccines within a month.  My influenza vaccine was on 11/20/2021.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/23/2023 Discharge Date: 3/28/23  PRESENTING PROBLEM: Cystic fibrosis [E84.9] Status post lung transplantation [Z94.2] COVID [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE:   47 yo s/p double bilateral lung transplant 1/11/1993, ESRD post renal transplant 1998, PTLD, right bronchial stenosis, bronchiectasis,  recurrent pneumonia (stenotrophomonas, pseudomonas, and MSSA) , recent rhino-enterovirus pneumonia Jan 2023, presented to ER with one week of worsening wheezing, fatigue, and night sweats. Did not have increased cough, sputum production, or hypoxemia. ER workup found RLL PNA and film array + COVID 19.  He was admitted for treatment.    Pt given a 5 day course of remdisivir. He was also treated for suspected secondary bacterial infection, initially with Doxycycline to cover his hx of MSSA then extended to minocycline that is sensitive to the stenotrophomonas he is colonized with (and grew on sputum). He developed worsening secretion retention once admitted therefore bronchoscopy was completed morning of discharge, moderate mucus plugging identified and BAL cultures pending . He overall was feeling well and discharged 3/28/23 with instructions to follow up with local pulmonary clinic and  transplant clinic.
an expired PENTACEL vaccine was administered with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient and reporter reported an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) for Prophylactic vaccination.  On 23-Mar-2023, the patient received 0.5 ml Total (1X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Frequency- once; Strength-standard) (with an unknown dose number) (lot number: UJ651AAA, Expiry date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation.  On 23-Mar-2023, the reporter reported an expired of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was administered with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Medical assistant reporting that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients. This situation is reported as a medication error due to the administration of an expired vaccine.  Action taken: not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 4-5 min post admin. of TDC, VZV, MMR and IPV (1st immun since child was 6 mo old). Child  "feeling funny" the immediately said her tongue was feeling thick and she was having difficulty swallowing since the reaction worsened over and appeared to begin to be severe and the hospital is across the st. The family immediately carried her to the hosp. accompanied by RN. I phoned hosp of situation. Child's personal MD was there. She was observed and sent home post 30 min-father was told to feed lunch and give her Benadryl po 4 hrs relieve the swelling on the lips. Dx mild anaphyalctic reaction to tetanus.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported   as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
A 8 months old patient received FLUBLOCK with no reported adverse event.; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via regulatory authority (Reference number- 00822512) and transmitted to Sanofi on 21-Oct-2021.  This case involves an 8-month-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccine.   On 19-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ724AA, expiry: 30-Jun-2022, formulation: pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "The caller is asking recommendations for a patient given FLUBLOCK at 8 months old?"  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme chills, nausea, extreme headache, and stomachache, treated with Tylenol with minimal relief
joint pain; increased saliva production; chills; temperature was 98.4; eyes were tearing; shaking; pain at the injection site; headache; nausea; abdominal pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (abdominal pain), SALIVARY HYPERSECRETION (increased saliva production), LACRIMATION INCREASED (eyes were tearing), TREMOR (shaking) and ARTHRALGIA (joint pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL PAIN (abdominal pain), LACRIMATION INCREASED (eyes were tearing), TREMOR (shaking), INJECTION SITE PAIN (pain at the injection site), HEADACHE (headache), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature was 98.4). On an unknown date, the patient experienced SALIVARY HYPERSECRETION (increased saliva production), ARTHRALGIA (joint pain) and CHILLS (chills). On 04-Mar-2021, ABDOMINAL PAIN (abdominal pain), SALIVARY HYPERSECRETION (increased saliva production), LACRIMATION INCREASED (eyes were tearing), TREMOR (shaking), ARTHRALGIA (joint pain), INJECTION SITE PAIN (pain at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and BODY TEMPERATURE INCREASED (temperature was 98.4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 98.4 degree Celsius.     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.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Chronic, spontaneous urticaria started after first COVID-19 vaccine. Worsening of urticaria after second vaccine.  Persistent urticaria for the past year.