chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to the pharmacy to receive a flu shot and reported swelling at the injection site, pain, and redness. She said the symptoms were really extreme and persisted for multiple days. She said she used NSAIDs to treat the symptoms.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-MAY-2017 the patient was vaccinated with VAQTA lot # L023232 for prophylaxis. On 23-MAY-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.; Sender's Comments: US-009507513-1709USA003272: US-009507513-1709USA003273:
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date 7th February 2021) for prophylaxis. On 4th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills, lethargy and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up. For tolerance after 2nd dose, refer case US2019042944.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that with a two to six month lead time, she had spent hours calling local pharmacies that were listed on website, but none of them had any shots. The patient was running out of time in her six month window and reported how painful the first shot was. She did not want to have to start over.
Caller states his wife took 1st Modena vaccine yesterday approx. 5 PM.  Starting around 3am this morning, she developed pain in her left arm radiating down her arm, chills and an elevated temp that is not responding to Tylenol or Motrin.  Temp has gone from 99 to 102 since 3 am today.  Encouraged her to go to ED or urgent care for evaluation of same.  RN
Arthralgia, Fatigue, Chills, Injection site pain and swelling Narrative:
No adverse event; Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023).    No concomitant medications were reported.  On 27-Sep-2022, patient received Pfizer Bivalent.  No treatment information was provided.
24APR97 pt arm became red, hot w/blisters;also running fever; pt was taken to MD on 25APR97;had OM & was placed on med for that;was instructed to go to clinic;22JUN93 DT given-reporter does not know why pertussis wasn't given;
This case was reported by a pharmacist via call center representative and described the occurrence of lost consciousness in a 70-year-old female patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included low blood pressure. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced lost consciousness (serious criteria GSK medically significant) and dizzy spells. On an unknown date, the patient experienced double vision. On an unknown date, the outcome of the lost consciousness and dizzy spells were recovered/resolved and the outcome of the double vision was unknown. It was unknown if the reporter considered the lost consciousness, dizzy spells and double vision to be related to SHINGRIX. Additional details were received as follows: This case was previously reported to the physician. The patient received SHINGRIX vaccine in left arm. On the day of reporting, the patient came into the pharmacy for 2nd dose, however, pharmacist advised patient to follow up with primary care provider before getting the 2nd dose of SHINGRIX. The reporter stated that the next morning after receiving the vaccine, the patient experienced a dizzy spell and lost consciousness. Caller states that the patient went to the emergency room. However, the cause of the symptoms were unknown. Upon call transfer, the reporter additionally stated that the next morning after receiving SHINGRIX, the patient was seeing double, then blacked out.
Patient had 2 adverse reactions with the same administration of vaccine (2nd dose).  At the day of the vaccine, patient started with leg weakness and a sensation of "heaviness" and tremors.  Received hydration at ER Room. But 2 days later, developed severe lymphadenopathy at axilla of the same arm (right) where received vaccine.
Muscle aches beginning at arms and shoulders and expanding over three days to hips and hamstrings, making it difficult to perform daily tasks and impossible to lift simple things without shaking. I began 60 mg of pregnisone for 10 days with dosage diminishing to 0 after four weeks. My symptoms returned within days. I am currently on a low, 10mg once or twice a day until blood tests come back, The initial diagnoses is severe tendonitis due to immune reaction.
deathly ill; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a social media via consumer.  This case involves patient (unknown demographics) who experienced deathly ill (illness), while he/she received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Got deathly ill with the regular flu shot ended up in the hospital, not asking a chance on this one. Medication details and reason for taking the medicine: route of administration: unknown Indication: unknown dose- unknown product name: product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
experiencing some numbness; tingling in tongue; tingling in lips on the left side; site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Allergies to medications, food, or other products were reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) in the left arm on 19Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 Vaccination. On 14Apr2021 the patient experienced 4 hours after the stick, experienced some numbness/ tingling in tongue and lips on the left side only. Only other side effect is site soreness. Therapeutic measures were taken as a result of the events, numbness/ tingling in tongue and lips on the left side only. Only other side effect is site soreness which included treatment with dyphenhydramine. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experiencing some numbness/tingling in my tongue and lips on the left side only and only other side effect is site soreness was unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Report described swelling at the injection site in a 54 year old female who received hep A vaccine. This report was received from a corpsman and has not been verified by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were unknown. On 04/11/2001, the vaccinee received her first SQ dose of Havrix. Post vaccination, she reported swelling from shoulder to elbow of the injection arm. The arm circumference was not measured. The reporter stated that the pt's arm was blowing up like a balloon. The pt had self-treated with ice on 04/11/2001. At the time of the report, the pt was being seen by a physician, who probably was going to give her a steroid injection for the swelling. As of 04/12/2001, the outcome of the event was unknown.
Sore at injection site.  Low fever, chills, bone and muscle aches, mild headache.
April 3, 2015 she was admitted into the hospital with chest pain. She was diagnosed with a Pericardial Effusion. She had to have a Pericardial Window to remove fluid from her heart.
This is booster.; This is booster.; scalding nerve pain; searing muscle pain; very weak muscles (cant hold phone more than seconds); nausea (unable to eat); profound fatigue; headache; dizzy; slow thinking; unable to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 24Aug2021 as DOSE 3, SINGLE for covid-19 immunisation  .    Medical history included ,chronic obstructive pulmonary disease from, breast cancer female, hypersensitivity.There were no concomitant medications.  The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, theophylline and experienced drug hypersensitivity.  On 24Aug2021 12:00 the patient experienced this is booster (off label use), All systemic, not just arm: scalding nerve pain, searing muscle pain, stiff painful joints, very weak muscles (cant hold phone more than seconds), nausea (unable to eat), profound fatigue, headache, dizzy, slow thinking.The outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have facial fillers.  My face is hot, red and very inflamed, except my forehead (no fillers) area around mouth (lip fillers).  Has lasted more than 2 days.  Visited physician thinking I had a sinus infection and was give 4 days of 40 mg steroids and augmenten anitbiotic.  Have taken 2 doses and little improvement.
Fever 101.5, neck stiffen up could not move. The muscle on the leg did not want to move they felt like jelly. Losing feeling all over. Started on the left and moved on the right side while in the hospital. No control in moving foot. Lumbar puncture it came back positive for protein. Trying to find out if she has MS.
Pain in shoulder, fever, H/A, body aches, swelling under the armpit x 3 days.
Approximately 45 minutes after receiving vaccine patient reported nausea, lightheadedness, and throat tightness.  Seen in the Emergency Department and received Prednisone and Benadryl.  Was monitored and discharged to home with home care advice.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Dementia and Heart disease, unspecified.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (hives). On 30-Mar-2021, URTICARIA (hives) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
vomiting phlegm; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and VOMITING (vomiting phlegm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism and Multiple sclerosis. Concurrent medical conditions included Allergy to topical drugs (Allergies to aspirin, penicillin and gadolinium). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and Jelena for an unknown indication.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing). On 27-Jan-2021, the patient experienced VOMITING (vomiting phlegm). At the time of the report, DYSPNOEA (difficulty breathing) and VOMITING (vomiting phlegm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a physician via a sales representative and described the occurrence of swelling in a 5 year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date, the subject received a dose of Infanrix (dose number not specified, lot number AC14A008AA). on an unspecified date before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling, redness and bruising. At the time of reporting, the outcome and causality was unknown
This spontaneous case, initially received on 20-Dec-2017 from other non-health professional, concerning a 28-year-old, adult, female pregnant patient of weight 110 lbs and height 62 cm. The patient had no history of pregnancies and concomitant diseases. The concomitant medication included VITAFOL ONE. The patient had no habit of tobacco, alcohol or illicit drug use. The patient last menstrual period was reported as 10-Apr-2017. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, anatomical location, route of administration and expiry date: not reported) at 23th week of pregnancy (explicitly considered as vaccine exposure during pregnancy). The patient had no pregnancy complications. It was reported that there is no evidence of defect/adverse finding from a prenatal test and patient had no adverse pregnancy outcome, birth defect/congenital anomalies and spontaneous abortion. It was reported that there was no adverse event reported in the pregnant woman and foetus. The estimated date of delivery (EDD) on 15-Jan-2018. The reporter assessed this case as non-serious.
Arm was tender; Arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELATONIN 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 an unknown date, the patient experienced TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful). At the time of the report, TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful) outcome was unknown. Not Provided          Patient was taking Melatonin 2 mg day after second dose.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-067580 (Patient Link).
Pt. given vaccine 5/4/2017 - Had prolonged localized reaction, painful, edematous, erythemic x 5 days.
a dose of Menveo/ Fluarix on February 19th 2022 and  second dose on February 21st 2022; dose of Bexsero on February 19th 2022 and  second dose on February 21st 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA568A, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3xe27, expiry date 30th June 2022) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo), Men B NVS (Bexsero) and Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season).   On 21st February 2022, the patient received the 2nd dose of Menveo, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st February 2022, unknown after receiving Menveo, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered and drug dose administration interval too short. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 2nd dose of Menveo and Fluarix Quadrivalent 2021-2022 season, which led to extra dose administered and 2nd dose of Bexsero, earlier than the recommended schedule which led to shortening of vaccination schedule. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022032526:case deleted US-GLAXOSMITHKLINE-US2022032527:case deleted
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 79 or 80 years old. The patient received the vaccine in the unknown deltoid. The healthcare professional reported that on 3rd January 2019, the patient stated that the injection site still had soreness in the shoulder.
pt recv vax 21SEP98 & returned to ER later that day w/an inj site rxn characterized by redness, pain, mild swelling & warmth;
tiny pin point of blood in his arm after the administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "tiny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "tiny pin point of blood in his arm after the administration".  Additional information: Caller explained that, for the first four doses, he did not had any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number;