chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 days post vaccine: arm is red and swollen, site is hot to the touch and I have a fever.  Other than a sore arm and slight swelling at injection site for ~36hrs after the shot, I had no other side affects until today, 9 days later.
left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine yesterday (15Jan2021). She was reporting symptoms that started yesterday evening at 21:00. On her left arm where the injection was, was swollen, itchy and painful most of the night and hurts even when she's not moving it. She wanted to know if this is normal, how long does it last and what she can do to treat it. She doesn't know if she can put icepack on it or take a shower. She asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
No adverse side effects reports mother. Was given Tdap vaccine instead of DTaP vaccine by mistake.
no adverse event; improperly stored vaccine was administered; This spontaneous report was received from an administrator and refers to a patient of unknown age an gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On  07-JUL-2023, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1925936, (expiration date: 28-MAR-2024), administered orally for prophylaxis (strength was not provided) (product storage error). The suspect vaccine was exposed to a temperature above 9 degree Celsius (C) (10.17 C) for a time frame of 1hour and 15 minutes 0 seconds. Previous temperature excursion was not provided. The patient no experienced any adverse event (no adverse event).
11/09/21 presents to local ED for "cough that started yesterday with a headache that started early this morning at 0200 with nausea and decreased appetite". PMHx "HTN, HLP, GERD, cancerous colon polyp s/p partial colectomy".
Hospitalization for CHF exacerbation, COVID 1/31/22-2/3/22. Treated with  zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
Weak; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak) and DIZZINESS (Dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included FOSINOPRIL, AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Weak) and DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Weak) and DIZZINESS (Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter. Concomitant medications also include eye drops.
Mild arm soreness Narrative: Mild arm soreness approximately 18 hours post injection.
Fever 104.7, Myoclonic movements, joint pain,- given ibuprofen, TYLENOL, IV ROCEPHIN: adverse reaction began within 1 hour of vaccine administration and continued to worsen until the next day at which time he was taken to E.R. and transported via ambulance to hospital. ?apnea. Febrile SZ x >5min.  6/11/09 MR received for DOS 5/30/09-6/1/09 with dx: Suspected Seizure Disorder (Atypical Complex Seizure).  Pyrexia.  Pt presented after episode unresponsiveness, frothing at the mouth and eyes rolled back, preceded by fever of 102'F and fussiness on the day of 1 yr shots.  Speaking incoherently after.  Parent reports recent episode of brief jerking/shaking, and eyes rolling back without LOC x 1 month. W/U (-).  D/C for outpt EEG. ICD9: 780.32   8/3/09 Hospital records received DOS 5/29/09 to 6/1/09. Assessment: febrile seizure, suspected sepsis. Patient presents with fever and 'chilling' for 36 hours. Will not bear weight on legs and is fussy. Looked glazed over. Unresponsive for 5 minutes. Vomited and cried.
About 5-10 minutes after getting shots, child starting having difficulty breathin, running nose, watery eyes
Pt recv vax on 1/5/98; on same morning pt exp groggy x 1-2 hr, inconsolable crying/screaming x 12 hr, not eating, tremors,no use rt arm, sleepless,ADHD sx, cont respiratory virus x 1 mon-cough, eye drainage,fever, nosebleed; tx=infant Tylen
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/30/2022 ANEMIA  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/30/2022 FAILURE TO THRIVE SYNDROME, ADULT
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects) 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 01-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 ADVERSE DRUG REACTION (side effects). At the time of the report, ADVERSE DRUG REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Localized rash to arm, itchy. Advised Ibuprofen, BENADRYL and hydrocortisone.
The skin area where patient received Pneumovax vaccine became red and inflamed a few hours after the patient came home from pharmacy. Patient put ice on the area but area did not resolved. Patient called pharmacy next evening 8/29/16 @ 6 PM and was instructed by pharmacist to take Benadryl and ibuprofen. Pharmacy called patient on 8/30/16 and patient reported redness improving.
died; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date due to unknown cause of death. Unknown treatment received. It was unknown if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died
administration of an expired dose of FLUZONE QIV NP to a patient who was pregnant with no reported adverse event; administration of an expired dose of FLUZONE QIV NP to a patient who was pregnant with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of administration of an expired dose of FLUZONE QIVNP to a patient who was pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On an unknown date nurse reporting the administration of an expired dose of FLUZONE QIV (lot UT7336LA,30-Jun-2022) to patient who was pregnant (exposure during pregnancy) (expired product administered) (latency: same day). This situation is reported as a medication error due to a pregnant patient being administered FLUZONE QIV NP after the expiration date.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
10/19/2011 patient came in to Health Department this morning stating ever since getting MMR vaccine, her neck has been hurting and joints have been aching. Asked if seen doctor and she replied no. advised to see doctor.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 13-MAR-2017, the patient was vaccinated with an expired dose VAQTA 50/1 units(U)/ml injection, lot # L023232 , expiration date: 25-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
PT HAD FLU SHOT LAST WEEKAND HAS BEEN COUGHING SINCE SHE GOT IT; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2101701, expiry date 30th September 2020) for pulmonary arterial hypertension, macitentan (Opsumit) for an unknown indication and sildenafil citrate (Revatio) for an unknown indication.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st January 2015, the patient started Tyvaso 1 dosage form(s) 4 times daily (4 dosage form(s) daily). On an unknown date, the patient started Opsumit at an unknown dose and frequency and Revatio at an unknown dose and frequency. In November 2019, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced cough. The action taken with Tyvaso was unknown. The action taken with Opsumit was unknown. The action taken with Revatio was unknown. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient had flu shot in last week and had been coughing since she got it. The patient went to primary care physician and had chest x-ray and it was negative. No further details were provided. It was unknown if the reporter considered the cough to be related to Tyvaso, Opsumit and Revatio. The reporter consented to follow up.
Vaccine given at 10:45 then at 11:00 Patient reported muscle pain around injection site as well as joint pain near the shoulder and elbow.
fatigue; total body aches; brain fog; headache; swollen/painful axillary left lymph node; swollen/painful axillary left lymph node; Low-grade fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 10:15 (Lot number: EW0217) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 29 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 29 years old, for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "Low-grade fever"; CHILLS (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Oct2021, outcome "recovering", described as "total body aches"; FEELING ABNORMAL (non-serious) with onset 14Oct2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 14Oct2021, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 14Oct2021, outcome "recovering" and all described as "swollen/painful axillary left lymph node"; FATIGUE (non-serious) with onset 15Oct2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, feeling abnormal, headache, lymphadenopathy, lymph node pain, fatigue.  Additional Information: Facility type Vaccine: workplace clinic, If other vaccine in four weeks: No, Other medications in two weeks: Yes, if covid prior vaccination- No, if covid tested post vaccination- No, known allergies- no, other medical history- none.  Follow-up attempts are completed. No further information is expected.
Mine are internal; Was on my deathbed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Mine are internal) and feeling bad (Verbatim: Was on my deathbed). The outcome of the shingles was not reported and the outcome of the feeling bad was resolved.   It was unknown if the reporter considered the shingles and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the shingles and feeling bad to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, misery, her/his are internal. The patient just took the first vaccine and was on her/his deathbed for over a week.  Not quite sure he/she will risk the second but patient don't want shingles again either. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Reports left shoulder pain that began within hours of vaccination.  States that it felt like vaccine "hit the bone" upon administration.
This spontaneous report as received from a registered nurse refers to a 8 week old patient who on 18-JUL-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number 1690AA) that was expired. The vaccine expired on 11-JUL-2013.  No adverse effects were reported. Additional information has been requested.
Possible stroke symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-May-2021 to 15-May-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) ongoing since an unknown date for Stroke, at a dose of 800 milligram; ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date for Stroke, at a dose of UNK dosage form; FENOFIBRATE ongoing since an unknown date for Stroke, at a dose of 54 milligram and PREDNISONE ongoing since an unknown date for Stroke, at a dose of 10 milligram. At the time of the report, CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received a Shingrix vaccine in Sept, 2020 and has not received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in September 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a Shingrix vaccine in Sept, 2020 and has not received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 Till date the patient had not received the 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter was not sure if patient needs to start over again or she could only administer 2nd dose. This case is linked with US2021019660, US2021019656 and US2021001321, reported by same reporter. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GSK-US2021019660:Same reporter US-GSK-US2021019656:Same reporter US-GSK-US2021001321:Same reporter
The first of the two vaccines (5/30/18) just caused minor arm soreness for about 48 hours. I don't recall which arm the 1st dose was given. The 2nd dose given on 8/9/18 (in the right arm) caused moderate soreness in the arm, and for about 4-5 days, aproximately. About 10-14 days after the 2nd dose, I began feeling an issue with  what felt like a tendon or ligament problem in the right elbow area, extending UP the arm about 6-8 inches and below the elbow about 3-4 inches. It was most noticeable during a SPECIFIC motion of the right arm. I can only describe the motion as folllows: Grasping even just a full tall glass of water and lifting it towards my mouth. VERY painful. PCP checked out the arm, asking me to do various things with the arm, none of which caused any discomfort. I showed him the motion that was causing the pain, and he was a little baffled. It SEEMED at the time of the visit 10/15 that it felt a little better. But it really isn't. Nothing I did with the arm initiated the problem.
Numbness and tingling in face, lips, tongue, arm and fingers: also swelling of tongue and lips: vomiting :HA all s/s started early am 12-04-1: saw RNP @ the doctor's office-she (per pt's gm) stated that pt had a stomach virus, probably unrelated to the flu shot.
15 year-old Given Heplisav-B; Initial Report Received on 23-Jul-2021  A Medical Center Operations Director reported that a 15 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.  On 27-May-2021, the recipient received dose 1 of HEPLISAV-B (Lot # 93767, Expiration 11-Apr-2022; NDC # not reported) in the right deltoid.    On 23-Jul-2021, the recipient presented for the second dose.  The recipient reported he has not had any adverse reactions from the first dose.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The soreness in her left arm (at injection site); Several flu-like symptoms developed; Not able to sleep through the night; Pt stated this shot "knocked her for a loop"; Headache; Shivering / chills; Myalgia; Fatigue; Still "walking slowly"; Feels unwell / "under the weather"; Feeling hung over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 8th or 9th October 2020, refer case US2020246456) and Flu vaccine with an associated reaction of chills (received on 8th or 9th October 2020).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, difficulty sleeping, discomfort, headache, chills, myalgia, fatigue, walking difficulty, feeling unwell and hangover effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills and fatigue were not recovered/not resolved and the outcome of the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect were unknown and the outcome of the headache and myalgia were recovering/resolving.   The reporter considered the injection site pain, headache, chills, myalgia and fatigue to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the night of vaccination she did had some soreness in her left arm but no (systemic) other symptoms before bedtime, during the night however several flu-like symptoms developed and she was not able to sleep through the night because she kept waking up with symptoms. The patient stated that this 2nd dose of Shingrix knocked her for a loop.   The patient had a bad headache and the headache was going away, she did not take any medication to treat the headache. She had shivering/chills, the shivering had resolved though she still feels a little chilled. She had myalgia, she says it was still going on but getting better. The patient reported she experienced fatigue.  On the morning of reporting she stated she was feeling a little better now that she has eaten breakfast and had some coffee. The patient stated that she was still walking slowly because she feels unwell and under the weather and feeling hung over. At the time of this reporting, the soreness in her left arm (at injection site) was still sore to the touch. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246456:Same reporter. 1st dose