chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 16 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that they inadvertently gave expired FLUMIST (last years vaccine) which started on 16-Sep-2013. The outcome of the event of INADVERTENTLY GAVE EXPIRED FLUMIST (last years vaccine) is unknown. The report was considered to be non-serious.
Pt came in with an egg size hard, swollen, red lump on deltoid muscle where MMR was given L. No treatment; just Ibu and ice.
From what I understand the night of the dose she had chills and a headache. She had several bad headaches since that vaccine up until her death on April 21st.  She was given the J&J vaccine on April 8th at the CVS.  Died on April 21. at home. I just saw an article today, May 4th that about 1-2 hours from her death, another female in her 30's got the J&J vaccine on the SAME DATE April 8 and she died on APRIL 19th. Pretty close in deaths and same vaccine. IS IT CONNECTED?
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown, single (Lot number: FJ5682) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetics" (unspecified if ongoing); "Shellfish Allergy" (unspecified if ongoing), notes: Known allergies: Shellfish; "latex gloves Allergy" (unspecified if ongoing), notes: Known allergies: latex gloves. There were no concomitant medications or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 15Jun2022 to 20Jun2022. On 29Jun2022, the patient had COVID rebound.
began to ache 2 pm of day of vacination, could not sleep. shooting   pain ears, hands, head, much worse than 1st shot
Dizzy; uncoordinated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2OA) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia. Concomitant products included METFORMIN, HYDROXYUREA, IRON and ALOGLIPTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated). At the time of the report, DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and contains No new information
Swollen about the size of a golf ball, erythromatous, intense itching, painful on palpation, warm to touch.
p/receiving a dose of Typhoid vax, pt exp erythema & edema @ site of inject, along w/nausea & vomiting;
Patient notes that on 9/3 she had an anxiety attack with racing heart and nausea/vomiting. Three days prior to this one of her distant cousins had passed away from COVID and left a child behind that is similar to the age of her child. On 9/17 she had her 1st COVID vaccine (moderna) at a pharmacy. On 9/21 she had a racing heart beat and N/V that lasted for hours. The next day when she woke up she was better, but tired. She had her 2nd COVID vaccine on 10/15 and the next day she had chills and not feeling well. She went to her friend's house and then she headed home and as she was driving she felt terrible. She look at her smart watch and her HR was in the 190s. She slurred her words talking with her daughter. She pulled over and her husband came and took her to the local ER. She was told she had SVT and she was given diltiazem drip and her HR went down to 100-120, but never normal. She had a negative troponin, normal CXR, and negative CTA as her D-dimer was elevated. She was transferred to a local Hospital. She was told by cardiology that she was having a side effect from the COVID vaccine. The patient was put ton propranolol 120 mg daily and told to follow up with cardiology in 7-10 days. The patient has an appointment with cardiology, Dr., today at 4 pm.        She states that she feels fine and hasn't had any more episodes of tachycardia. She is only taking 60 mg of the propranolol as 120 mg made her feel bad.         Pt presents for transition of care management.
Skin itching, eye itching and nose bleeding/ inflammation since the day of vaccination till today.
Im recived my firts dosis of moderna covid 19 vaccine and i have breathless is normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Im recived my firts dosis of moderna covid 19 vaccine and i have breathless is normal) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Im recived my firts dosis of moderna covid 19 vaccine and i have breathless is normal). At the time of the report, DYSPNOEA (Im recived my firts dosis of moderna covid 19 vaccine and i have breathless is normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were not reported. No treatment medications were not provided.
first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021; sore arm; mild flu; sweat; maybe a headache; really tired; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache) and FATIGUE (really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021). In 2021, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna vaccine 12JAN2021 and second dose of the Moderna vaccine on 19 FEB 2021) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA (mild flu), HYPERHIDROSIS (sweat), HEADACHE (maybe a headache), FATIGUE (really tired) and PYREXIA (little bit of fever) outcome was unknown.            Patient concomitant mediation included thyroid medication which is used for product use for an unknown indication. Treatment information was not provided. Patient received the Moderna booster on 30-Oct-2021 with Lot No:25D21A and expiration date on 25-Jan-2022 Via IM route. And patient reported that she did not have any side effect for booster dose.   This case was linked to MOD-2021-377223 (Patient Link).
Scattered, confluent m-p rash to face, body and extremities - started around 11/30/02.
Headache 2 days     Chills 8 hours.      Fatigue 3 days Body aches 2 days
Within 8 hrs of receiving vax,pt dvlped extreme weakness, tiredness,headache,muscle ache,loss of appetite,& fever;stayed in bed.These symptoms lasted 6 days;on 7th day felt less weak, took naps-this lasted until 12th day.
fever; swelling at injection site; This spontaneous report was received from a health care professional concerning a female patient currently 76 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered as prophylaxis (formulation, strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with fever and swelling at injection site. The outcome of the events were not reported.   Additionally, the patient experienced acute kidney injury, metabolic acidosis, hypothyroidism, hypokalaemia, gastrointestinal disorder, malaise, pleuritic pain, blood creatinine abnormal, rash, asthenia, dyspnoea, pulmonary mass, insomnia, occult blood positive, anaemia, oesophagitis, candida infection, nausea, hypophagia, constipation, hyponatraemia, hypocalcaemia, hypomagnesaemia and vomiting (captured in MARRS# 2208USA009525).  The causal relationship between the events of fever and swelling at injection site were considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2209USA008773: US-009507513-2208USA009525:Original Case : 2208USA009525
48 hr post-vaccination, patient experienced red, painful, hard knot approximately 1/2 dollar size. Spoke with him 9/10/14 and knot has reduced in size and redness. Patient improving.
On 5/15/00, the pt received the DTaP vax. Mother noticed redness at site. On 5/17/00, the area had increased in redness and was hot and swollen, taken to ER and was admitted. Pt was treated with IV antibiotics, warm compresses, discharged on 5/18/00 on Keflex. Follow-up dated 9/6/00 provided no additional data.
Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. A 73 year-old elderly male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and an unspecified amount of time later was diagnosed with pneumonia and died 21 days after vaccination on 17 October 2014. The patient had a chest x-ray, WBC and CBC results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
a painful, swollen axillary lymph node; a painful, swollen axillary lymph node; This is a spontaneous report from a contactable consumer and non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. A week after the first dose patient noticed a painful, swollen axillary lymph node that went away after 2-3 days. The outcome of the events was recovered on unspecified date.  Information on the lot/ batch number has been requested.
patient has not received 2nd or 3rd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:  10-AUG-2022 Reporter's comments: The patient that received her first dose of Twinrix of 29th June 2022. At the time of reporting the patient had not received second or third dose.  The reporter consented to follow-up via email. Additional supportive information: Until the time of reporting, the patient did not receive the 2nd dose of vaccine, which led to incomplete course of vaccination.
Pt seen 8/17/06 per parent has had rash and fever x 1 wk. Temp 96.5 F, vesicular rash at different stages of crusting lower back and buttocks per MD eval. Tx acyclovir 200 mg susp 1 tsp 3x a day. Loratadine 5mg syrup 1 tsp daily PRN.
Pt took first dose of oral typhoid at 11pm on 12/30, on 12/31 at around 9pm, started vomiting & diarrhea for approximately 12 hours, Temp 102F.  Continues to have generalized weakness, no longer with fever or vomiting.  Some diarrhea.
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported. The age at vaccination was not reported. No further details were provided.
This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 21-JUL-2014 the patient was vaccinated with an expired dose of ROTATEQ (dose strength not reported) lot J002355, expiration date 10-JUL-2014, route oral. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681571, US-MODERNATX, INC.-MOD-2022-681675, US-MODERNATX, INC.-MOD-2022-681678 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681571:Same reporter US-MODERNATX, INC.-MOD-2022-681675:Same reporter US-MODERNATX, INC.-MOD-2022-681678:Same reporter
This was patients first covid vaccine given by nurse and he received Pfizer on 01/24/22 approximately 10:45am and about 1 minute later the patient told the nurse he was not feeling well. The nurse came and told the pharmacist on duty and the pharmacist asked the patient what is going on. He mentioned his heart was beating fast and he was having trouble breathing, however his airway was not closed and he did not pass out or did not have any rashes on his body that would indicate anaphylaxis. Blood pressure was checked and it was 143/100 and his BPM was 94. He was given water as well. Ambulance was called and they came in 10:57am and checked him and by that time patient was feeling good.  He said he felt like nothing ever happened and he might have just had a panic attack or was nervous. Paramedics checked his BP and it was 152/111 and overall they said the patient seems fine now and he is not experiencing anaphylaxis. Ambulance left and patient waited another 20 minutes, said he felt good and left at 11:20.  Patient was advised to follow up with primary care doctor about his high blood pressure
Patient c/o feeling tachycardia, flush and dizziness, flushness upper torso neck region and bilateral upper arms. Rash/hives not present. Placed on stretcher , monitored immediately with BP 156/100, HR 88, O2 99%, alert and oriented x3, verbalizing clearly. Placed on EKG monitor, noted in NSR 80. POC 102. Shortly after at 1001, redness subside ,briefly noted with tingling of bilateral feet and hands for only seconds. Patient was monitored for 40 minutes, returned to baseline 142/81 HR 58 O2 100%. Nutrition given . Discharged to home, ambulatory feeling well.
This spontaneous report was received from a pharmacist via company representative concerning a 21 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 21-AUG-2018, the patient inadvertently received first dose of HPV series of GARDASIL 9, which was expired lot number M018810 (EXP 18-MAY-2018) for prophylaxis (strength, route of administration, lot number were not reported). No adverse events reported. No further information provided.
rash on trunk and beck beginning 24-36 hours after vaccine. mostly resolved in 3-5 days but few itchy spots remain on back. treated with steroid cream at home
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, dose, route and frequency were unknown) which was expired on 10-AUG-2014. No adverse events were reported. Additional information has been requested.
accidentally reconstituted Shingrix with sterile water & administered to patient; accidentally reconstituted Shingrix with sterile water & administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular). On 27-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: accidentally reconstituted Shingrix with sterile water & administered to patient) and inappropriate dose of vaccine administered (Verbatim: accidentally reconstituted Shingrix with sterile water & administered to patient).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 27th August 2023: The reporter stated that accidentally reconstituted Shingrix with sterile water and administered to patient.  The reporter need information with how to proceed and guidance with 2nd dose of Shingrix. The reporter consented to follow up. The patient received Shingrix reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
felt kind of blah; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt kind of blah) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt kind of blah). At the time of the report, FEELING ABNORMAL (felt kind of blah) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to MOD21-088487, US-MODERNATX, INC.-MOD-2021-116586 (E2B Linked Report).; Sender's Comments:  MOD21-088487: US-MODERNATX, INC.-MOD-2021-116586:
pt recv vax 8OCT96 11AM & mom states got up from nap 1-130PM w/strange cry-high pitched;mom picked pt up felt rigid then relaxed;also seemed shaky, pale, lips & hands bluish;drowsy, trembling;felt hot, restless;MD stated no more pertu
Fluzone PFS, that were expired was administered to patient with no reported adverse event.; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was administered expired Influenza Quadrival A-B Vaccine (Fluzone Quadrivalent) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a dose of 0.5 mL frequency: once of suspect influenza quadrival A-B vaccine (with lot UT7378MA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylaxis.  On 07-Oct-2022 (latency: same day) the patient was administered Fluzone PFS, that were expired with no reported adverse event (expired product administered).   No lab data was reported.  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.