chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excruciation pain from shoulder to wrist; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciation pain from shoulder to wrist) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (excruciation pain from shoulder to wrist) and FATIGUE (fatigue). On 06-Apr-2021, PAIN IN EXTREMITY (excruciation pain from shoulder to wrist) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was not provided.
Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on a cot where she had a vasovagal response with loss of consciousness. Pt was disoriented x 2minutes. VS: BP 124/80, HR 86, O2 sat 100% room air, RR 18. Paramedics were called to evaluate patient. She was medically cleared by paramedics. Pt had a friend drive her home. Pt was stable when leaving.
Woke up and entire left side of body was swollen and dragging.  Went to the ER and was admitted and diagnosed with a stroke.
This spontaneous case, initially received from physician on 16-Oct-2018, concerning a 34-year-old, adult, male patient. The patient had no medical history and concomitant FLUCELVAX (QIVc) (dose: 0.5 ml, batch number: 252234, anatomical location: deltoid, expiry date: 30-Jun-2019 and route of administration: intramuscular). On or before 15-Oct-2018 (as reported by the physician), after vaccination, the patient developed a discoloration on his arm that has not resolved in several days. It looks dark (brownish colour), size 2-3 quarters and it's spread out in an irregular shape from the injection site. The physician also reported some pain and swelling. The patient did not receive any treatment till the date of the report. At the time of the report, the patient had not recovered from the events. The reporter assessed the event as non-serious.
Same day, skipped a few days, and pains/aches started happening all over inside body.  Not growing pain feelings, but electric type pinched nerve feelings, random and off and on continuously for nearly two weeks so far incuding chest pain, numb feelings, and weakness.  Lots of hip and leg and elbow pain.
Pt felt hot and short of breath . Pt recieved EPI in office and EMS was called . Pt was transported to the Hospital
Head in a fog; This case was reported by a nurse via call center representative and described the occurrence of foggy feeling in head in a 49-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, several years after receiving Tdap Vaccine, the patient experienced foggy feeling in head. On an unknown date, the outcome of the foggy feeling in head was unknown.   It was unknown if the reporter considered the foggy feeling in head to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient patient received an unknown brand of Tdap or Td vaccine over ten years ago and felt like his head was in a fog. The reporter did not consent to follow up.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4504739-00 (Abbvie).  A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
The recipient of the vaccine has reported that she  began experiencing "severe pain in her fingers later in the afternoon" on the day she  received the 1st dose of the vaccine.  She is currently receiving physical therapy and is being seen at a Center. She did not return for the 2nd dose.
both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shot (Patient states that the flu shot always takes her out.). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Chronic kidney disease stage 4 and Sodium. Concomitant products included LOSARTAN, CLONIDINE, ALLOPURINOL and FUROSEMIDE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.). At the time of the report, PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications are provided.  The patients Doctor says that the shot had nothing to do with it and that the patient's Blood Pressure medication is too blame. The patients feet are no longer swollen. The feet swelling got better after 3 weeks. The right leg swelling is better. The right leg swelling improved 3 to 5 weeks after the second Moderna Covid-19 vaccine. Left leg swelling remains an issue.
Redness; Pain; Swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. In July 2019, unknown after receiving Bexsero, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unknown.   It was unknown if the reporter considered the erythema, pain and swelling to be related to Bexsero.  Additional case details were reported as follows: The healthcare professional could not provide patient demographics, the number of patients, lot numbers, or expiration dates. The age at vaccination was not applicable for this report. The reporter reported several patients experienced a variety of events following Bexsero administration.  The patients experienced redness, pain, and swelling. The healthcare professional described pain as lasting for a couple of weeks in one patient.  The healthcare professional noted these events had been takes place over the last month, no specific time frame reported. No start or end date of any of the events provided. The reporter gave permission to follow up. This case had been linked to the case US2019151259, US2019151261 and US2019AMR157403 reported by same reporter.
Gave Tdap to new employee. She stated "can't remember last tetanus shot, so long ago." States rash and red arm after previous tetanus, but dr said was due to horse serum and not reason to avoid future tetanus shot. Developed flushed face and hives and felt like throat closing off. to ER ay 11:13 am. Epinephrine ZANTAC and steroids given. Released to home at 13:05.
sore and swollen arm for three days; sore and swollen arm for three days; severe headaches; clammy skin; blood pressure has been low; has no appetite; vertigo; having sweating; dizziness; This is a spontaneous report from a contactable consumer (patient mother) or other non-healthcare professional. A 47-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot number, Expiry date: Unknown), via an unspecified route of administration on 06Aug2021 (at the age of 47-year-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021 the patient experienced severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite. The patient received the first dose of the vaccine Pfizer since the patient been experiencing sweating and having headache and something that did not realize dizziness, the patient had dizziness where he's spinning the room is not spinning it is preventing him from going to work because he drives, now is this a possible side effect of the medication. Initially the patient experienced a sore and swollen arm for three days but that has now (at the time of report) subsided. The patient received Tylenol, 500 MG each, two tablets (twice a day) as a therapeutic measure for the events. The patient did not receive any treatment Prior Vaccination. The event sore and swollen arm was recovered, the events severe headaches, clammy skin, vertigo, his blood pressure has been low and has no appetite was not recovered and outcome of the events sweating, dizziness was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
she felt sleepy and cold; she felt sleepy and cold; a bit dizzy; This is a spontaneous report from a contactable consumer reported for cousin. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose (lot number: Ek5730) for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient got the vaccine on the morning of 23Dec2020. She said she felt sleepy and cold. The patient said she felt better this afternoon. A pinch, the patient felt cold and sleepy. She could take a nap. The patient felt a bit dizzy when she got out of her chair just now. Outcome of the events was recovering.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
she had been suffered with pain at the injection site at her left shoulder; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via call center.  This case involves a 69-year-old female patient who had been suffered with pain at the injection site at her left shoulder (injection site pain), while on influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2020 (3 weeks ago), the patient received on influenza quadrival a-b high dose hv vaccine, (formulation, strength, dose, frequency, batch number, expiration date, route of administration was unknown) at a 1 time dose in the right arm for prophylactic vaccination.  On 19-Oct-2020, 22 days after starting the suspect vaccine therapy it was reported that she had been suffering with pain at the injection site at her left shoulder. She contacted her HCP who advised her to treat it with interchanging heat and ice. Because the patient was still hurting today.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not resolved.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Severe
11 days post injection -- > Large Redness/Rash surrounding injection site; look to it -- > more red at the edges  Expanded overnight (1/18 /21-- > 1/19/21) Itchy  No other symptoms (no fever); redness localized to injection site
Inflammation, angioedema mouth, face, cheek, eye closed, swollen tongue.   25 mg oral Benadryl twice, Motrin 600 mg three time, medications taken over 24 hours.
Headache; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Lot number: EN6199) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness".  No follow-up attempts are possible. No further information is expected.
c/o lump on rt arm, sensitive to touch, purple, hard about 1/2" in diameter;otherwise healthy, no fever, eating well
Severe pain in axilla, which progressed to include pain in left arm, left breast, neck/jaw/ear and left upper back. Pain is constant in nature and movement aggravates the pain. Use of left arm is limited due to pain with exertion.
Adverse events: blister, whole upper arm swollen and hard, red, hot to touch. Low grade fever aches (lower back and hips). Treatment: triamcinolone cream and prednisone and AUGMENTIN.
This is a serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly female patient. On an unspecified date in 2017 (reported as last year), the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day after vaccination (reported as later), the patient developed fever and had nausea, vomiting and diarrhoea for 1 day. On an unspecified date, 4 months after vaccination, the patient developed flu. The lab test performed confirmed influenza virus B strain. At the time of this report, the outcome of the events was not reported.
This is a spontaneous report from a contactable nurse. This nurse reported for a 7-months-old, male consumer who received PREVNAR 13 on unknown date. The relevant medical history included viral illness and sore throat since an unknown date. The relevant concomitant medications included PEDIARIX at 0.5 cc, HIB at 0.5 cc and FLUZONE at 0.25 cc, all medications on unknown date for immunization. On 30Oct2012, the patient was administered with the expired PREVNAR 13 and after that on unknown date in 2012 he experienced fever. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported events were unknown. The clinical outcome of reported events was unknown. Follow-up (09DEC2012): Follow-up attempts completed. No further information expected.
lowoxygen; exhaustion; received a third dose; received a third dose; couldntot walk more than 10feet; difficulty to breath; This is a spontaneous report from a contactable consumer (the patient). An 87-year-old female patient received the third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448) via an unspecified route of administration in left arm on 16Aug2021 at age of 87-year-old (age at vaccination) at single dose for COVID-19 immunisation. Medical history included ongoing COPD/emphysema from 2010. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EN6199) intramuscular in left arm on 06Mar2021 for COVID-19 immunization; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number: EP7534) intramuscular in left arm on 27Mar2021 for COVID-19 immunization. It also reported the patient previously took FLU vaccine given the same day (the vaccination date was not specified), the patient have no information on it. The patient experienced exhaustion on 18Aug2021, the event was serious with seriousness criteria of persistent/significant disability, important medical event, treatment (additional predinasone) received for the event, the event required visit to-physician office. The patient experienced low oxygen on 25Aug2021, the event was serious with seriousness criteria of persistent/significant disability, life threating, important medical event, treatment (additional predinasone ,3 weeks) received for the event, the event required visit to-physician office. The patient stated about 10 days after combined vaccination oxygen level fell into the 80's. Could not walk more than 10 feet out of breathe (Aug2021). It has been 7 week and still difficult to breathe at times. within 2 day exhausted no energy, then problems breathing them low oxygen, getting better slowly. The outcome of the event(s) "received a third dose" was unknown, of other events was recovering.   Follow-up attempts are completed. No further information is expected.
Vaccine given to a 17 year old patient; A spontaneous report was received from a pharmacist concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)/Inappropriate schedule of product administration.  Medical history or concomitant product use was not reported.  On 14 Jan 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Feb 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 042L20A) intramuscularly in the left deltoid. It was reported that patient was only 17-year-old while vaccination.  The action taken with mRNA-1273 in response to the event was not applicable since the patient received both the doses.  The outcome of the event was considered as resolved on 11 Feb 2021.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 025J2--2A) with no associated AEs reported.
Local reaction x 3d - erythema, pruritus - progressive. 1) Symptomatic tx. 2) Prophylactic tx (antibiotic). 3) Follow up if symptoms persist > 7d.
Confusion, Headache, Myalgia, Arthralgia, Fever, Diarrhea NaseaVomiting,  had covid in January, painful, raised/red injection site, smell and taste of cigarette smoke. tylenol and motrin not helpful.  Narrative:
She has had severe pain from her shoulder all the way down to her hand. It is sore to the touch and she has not had a good night sleep since the shot because of the pain. She has done physical therapy and nothing has helped so she is now going to go see a MD.
received a second dose of FLUZONE HD QIV with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient who received a second dose of Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient second dose with dosage 0.7 ml of suspect Influenza Quadrival A-B High dose HV Vaccine (lot U8162CA, expiry date: 30-JUN-2024 with unknown strength)  via intramuscular route in the left deltoid as immunization with no reported adverse event (extra dose administered) (Latency: same day).  It was reported "The patient presented at their pharmacy and requested a flu vaccine. After administration, the patient stated that he meant to ask for a COVID vaccine instead because he had already received his flu vaccine at his HCP (Healthcare professional). Caller requested any safety information available."   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.
Hip thing, a heat in the underback of her hip; Little pain down in her uterus; heat on top of head; muscle sore; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe headache). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Initial solicited report received from a consumer (online market research respondent) in the study on 04 December 2015. The subject (gender and age were not reported) received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE on an unspecified date, (site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion the subject reported that, the subject received the vaccine last season and had found it ineffective. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.