chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest tightness; chills; energy loss; tired; headache; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (energy loss), CHEST DISCOMFORT (chest tightness), CHILLS (chills), HEADACHE (headache) and FATIGUE (tired) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified and Heart attack in 2019. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, CLOPIDOGREL, LISINOPRIL, METOPROLOL and NITROGLYCERIN for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced HEADACHE (headache). On 07-May-2021, the patient experienced ASTHENIA (energy loss), CHILLS (chills) and FATIGUE (tired). On 11-May-2021, the patient experienced CHEST DISCOMFORT (chest tightness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form twice a day. At the time of the report, ASTHENIA (energy loss), CHEST DISCOMFORT (chest tightness), CHILLS (chills), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis.  The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported.  On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Pediarix in an unspecified thigh.  At an unspecified time after vaccination with Pediarix, the subject experienced welt injection site.  The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly."  At the time of initial reporting the outcome of the events was unspecified.  Follow-up information received on 11 May 2007 indicated that Pediarix was inadvertently administered to the subject subcutaneously.  The events did resolve and according to the reporter, they were related to administration of Pediarix.
This case was reported by a healthcare professional and described the occurrence of inappropriate dose of vaccine administered in a 21-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Previous and/or concurrent vaccination included tetanus and diphtheria toxoids adsorbed;  manufacturer unspecified; unknown given on 27 June 2005.  On 27 June 2005, 17 August 2005 and 26 June 2006 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (.5 ml, unknown).  The subject experienced inappropriate dose of vaccine administered and inappropriate schedule of drug administration.  The healthcare professional stated that no adverse event were reported.  They are doing laboratory work to see if the subject is protected.  Follow-up information was received on 11 December 2007, via healthcare professional, who reported the events were associated with lack of efficacy because not enough vaccine was administered.  On 19 November 2007, the subject had a hepatitis B surface antigen (quant) performed;  the results were >1000.  No other information was provided.
Pt (R) arm red from shoulder to elbow (anterior), no swelling, no drainage or heat. Pt denies pain. Methylprednisolone 6, 5, 4, 3, 2, 1 dose pak tab every day.
Patient received first dose of Jynneos intradermally; Case reference number US-BN-2022-002629 is a spontaneous case report initially received from other health care professional (reference number: USBAV22-1451) on 01-Sep-2022 and concerns a male patient of unknown age.  The patient's past medical drug included ACAM2000 (smallpox vaccine).   The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) administered intradermally (explicitly coded as 'intradermal injection') at an unknown dose or site of administration for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos   Additional information received from Bavarian Nordic on 20-Sep-2022 included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, the vaccine was administered intradermally, and this is coded as intradermal injection. The event is considered listed as per the Company. The patient's past medical drug included ACAM2000 (smallpox vaccine) and patient's concomitant medications were not provided. It's unknown if the patient experienced any adverse events following vaccination. Case is non-serious. Based on information provided, causality is assessed as not related to the suspect vaccine, but to a human action.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, the vaccine was administered intradermally, and this is coded as intradermal injection. The event is considered listed as per the Company. The patient's past medical drug included ACAM2000 (smallpox vaccine) and patient's concomitant medications were not provided. It's unknown if the patient experienced any adverse events following vaccination. Case is non-serious. Based on information provided, causality is assessed as not related to the suspect vaccine, but to a human action.
Initial report received from a healthcare professional on 18 August 2014. A 66-year-old male patient, had received second dose of FLUZONE HD, (batch number U5015AA, route not reported in the left deltoid) on 15 August 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unaware. Concomitant medications were not reported. On 15 August 2014, same day after vaccination, the patient developed a lump at injection site with tenderness. The arm was very sore and swollen with a lump and it had a large amount of bruising around site. Patient applied ice to site over weekend. To rule out possibility of allergy, patient was also advised to take BENADRYL and MOTRIN by pharmacist. Patient denied use of blood thinners. Complementary investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 4 of 15 (A0860669A, A0860688A, A0860692A - A0860702A for the other reports).
pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially  hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia.  cardiology saw her. she was started on a heparin drip.  infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021.
I got the second shot on 04/17/2021 and about a month later I developed a mushy lump under my left armpit. I went to my gynecologist and I had an ultrasound on it. They said the lymph nodes were fine but it does gives me some trouble. Sometimes my fingers go numb and I have to adjust the way I have my arm. I had a mammogram 2 weeks ago and a biopsy on Monday and there was a lump in my lymph node. I am still waiting for the results. My GP gave me an antibiotic and it did not go down.
My neck got stiff on the right side; slight headache; dizziness; face turned red got very hot; face turned red got very hot; the right side of my face went numb; Facial flushing; vasodilation 15 min after administration; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: Fr8731), via intramuscular route of administration, administered in Arm Right on 01Jun2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, arthropod sting from an unknown date and unknown if ongoing known allergies Bee stings, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa, back pain from an unknown date and unknown if ongoing other medical history chronic back pain. Concomitant medications included cetirizine hydrochloride; asa (ASA). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 10:15, the patient experienced my neck got stiff on the right side, slight headache, dizziness, face turned red got very hot, face turned red got very hot, the right side of my face went numb, facial flushing, vasodilation 15 min after administration. The outcome of the evens was not recovered.  Follow-up attempts completed. No further information expected.
Fever; Chills; Body aches; Shivers; Nausea; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary series of Immunization completed, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Shivers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain, chills, nausea, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Henoch-Schonlien Purpura. Abdominal pain, rash covering legs and torso, abdominal pain, joint pain leg pain
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Tachycardia, , chills, fatigue, weakness Narrative:
Moderna Covid-19 Vaccine  sore arm, severe chills the night after the vaccine administered,
Patient received IPOL that had already expired on 03-May-2020/ No AE; Initial information was received on 04-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four years old female patient who was inadvertently vaccinated with 0.5 mL dose of expired vaccine IPV (VERO) [IPOL] (4th dose in series, lot P1A461M and expiry date 03-May-2020) via intramuscular route in the left thigh on 04-May-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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 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.
About 30 min after shot, I was driving home and started having trouble swallowing.  It felt like something was stuck in my throat.  The next day,  the feeling wasnt quite as bad, but my throat was burning really bad
swelling & redness @ site, arm & shoulder hurt muscular type pain in chest-felt joint & sick-went to clinic 20JUN97 where MD identified this as allergy to vax & pt given DPH told to get next vax 26JUN97;
Pt had febrile seizure x 2; also had OM & pharyngitis @ same time; adm to hosp for further rx & dx complex febrile seizure about 12 minutes in duration;
First, chills, then 102.7 degree fever. Weakness and lethargic. No appetite, drank fluids. Applied ice pack to red swollen inj. site. This lasted 3+ days. Felt puny and weak. Saw pharmacist who gave shot, said it was new batch, me and 2nd patient had same reactions. Saw Dr. gave me blood tests.
Small knot formed at injection site  on day 8 and started itching. On day 9 a red rash appeared around the injection site about the size of a baseball. I have not went to seek medical advice
First dose almost one year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose almost one year ago with batch number K7T79).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The patient asked that he/she have to start the series over, since it was been more than six months or might he/she just count this next dose as the second. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
had the shot it would have been worse/suspected vaccination failure; had the shot it would have been worse; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. The patient had gone to one doctor and emergency department, they did not know what it was, then the patient went to another doctor who knew what it was the minute he saw. The patient stated that, it was very very painful, he/she had the shot it would have been worse. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Vertigo, brain fog, hearing loss; Menière syndrome was revived after 9 year without bothering, still ongoing 4 months later
I am 29 weeks pregnant and was ordered by my obgyn Dr to take the TDAP vaccine now for my baby to have coverage at birth since I am in my 3rd trimester.   I recieved the tdap vaccine 7/29/19.  Today 7/30/19 I woke up with a red swollen area on my left deltoid measuring 2inches by 2 inches approximately.  I've had the TDAP vaccine before and this has never happened.  I've also given this vaccine before to many children and never seen it happen so I feel it is necessary to report it.  My arm is extremely sore at this time.  I know I should have some soreness but this swelling and extreme pain is very concerning.
This spontaneous report as received from a registered nurse refers to her daughter, a 19 year old female patient with no reported medical history. On unspecified date in 1998 the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (route, dose, frequency and lot number unknown). No other suspect therapy or concomitant medication was reported. The nurse reports that her daughter received an unspecified varicella vaccine (that may or may not have been VARIVAX) on a unspecified date when she was 11 years old. Nurse assistant that her daughter since then has had shingles 3 times; once when she was 19 years old (on unspecified date in 2006), then when she 24 years old (on unspecified date in 2011), and the nurse assistant that she believes her daughter has the shingles again now (21-APR-2013) but with no rash present when she was 26 years old. No treatment information was reported. The outcome of shingles when she was 19 years old, shingles when she was 24 years old and shingles with no rash present when she was 26 years old is unknown. The reporters relatedness of shingles when she was 19 years old, shingles when she was 24 years old and shingles with no rash present when she was 26 years old to varicella virus vaccine live (manufacturer unknown) is unknown. Additional information has been requested.
Had 2.5 weeks of bleeding during menstruation including heavy bleeding. Pain at injection site for 3 days. 16 and 17 days after vaccinne administration had terrible headache, 100 degree fever, vomiting all day, body aches. 17 days after vaccine administration almost fainted and had to lay down for 30 minutes. Thought about going to urgent care. Finally on day 18 was feeling better. Will not be getting a Covid vaccine again because of side effects.  Also my 2 boys under age 18 will not be getting vaccine as long as there is a threat of serious side effects.
Skin: Inspection and palpation: right upper arm with ~7cm x 4.5cm area of erythema and warmth, tender to palpation at site of injection of Tdap. No induration. Patient Instructions Apply ice to the area, 20 minutes on and then at least 20 minutes off. Start the claritin and motrin Recheck if symptoms worsen or do not improve in 3 to 5 days.
Pt complaining of tongue pain with visible facial edema and bilateral eyelid swelling. Noted red raised bumps on tongue. Pt denies respiratory distress, speaking in complete sentences. Pt alert and answering questions appropriately. Pt given personal EPI pen at 1550, no improvement. EMS called and arrived at 1605. Parent advised to take pt to nearest hospital for evaluation. Pt escorted with parent to car. Pt remained stable.  Per pt's step mother, pt was taken to ER, Hospital.  Pt stable.  Family called the next day, father indicated that patient stayed hospital overnight for observation.  Symptoms were resoloving
There was a large welt at site of vaccine and then the welts were all over her body. Mainly trunk, legs, and arms. We went to the ER since her daycare wouldn't allow her in without a note stating she wasn't contagious. The doctors gave her Benadryl and sent us on our way. The rash moved then from her trunk to her face and mouth. I again took her to ER and they put her on prednisone and also a histamine blocker (I did not give her the histamine blcoker). Day three her red welts turned into purple bruises behind her legs, on her back and on her belly around her belly button. The large red welts remained and continued for 2 days to fade and reappear.
Patient more unsteady gait, shakiness, and weakness on 7/01/2022 around 0300. No new orders from doctor. Patient was on Neuro checks due to a fall from symptoms. By 07/03/2022 symptoms improved.
vomited; felt bad; Diarrhea episode; has bee up and down few pounds; feeling sick; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (041488).  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "not recovered", described as "vomited"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea episode"; WEIGHT ABNORMAL (non-serious), outcome "unknown", described as "has bee up and down few pounds"; MALAISE (non-serious), outcome "unknown", described as "feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.