chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward). At the time of the report, VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided. No treatment medication information provided. The patient only experienced site injection pain for 1 to 2 days.
Approximately 48 hours after receiving 2nd dose of the vaccine, vaccine site became swollen, red and hot.  Also the outside of the bicep was also swollen.  Symptoms lasted for a coupled of days.
Pt has new headache not relieved by tylenol or ibuprofen as well as dizziness, and vomiting.
On 6/6/2019 I administered Proquad which is MMR and varicella combined and a varicella. I was supposed to administer MMR and varicella separately. Mother was notified immediately and so were the nurses, I spoke to the provider and he stated the patient would be fine. I also contacted Merck to double check the patient would not be at risk.
Fatigue; injection site arm pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal allergy flare up : fatigue, H/A, stuffy nose, malaise.) since 14-Aug-2021, Sinus disorder NOS (sinus flare up : fatigue, H/A, stuffy nose, malaise.) since 14-Aug-2021 and Potassium low. Concomitant products included IPRATROPIUM BROMIDE (ATROVENT) from 14-Aug-2021 to 23-Aug-2021 for Allergy aggravated and Sinus disorder NOS, LOSARTAN and HCTZ for Blood pressure abnormal, POTASSIUM for Potassium decreased, COLECALCIFEROL (VIT D3) for Supplementation therapy.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021 at 3:00 PM, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills). On 18-Aug-2021, FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-255766 (Patient Link).
Date of event: 01/09/2020 . At 14:55- Received report from medical assistant. Patient's temp 97.2 F. Mom reports patient's been doing well, denies recent illness. Confirmed patient's name and DOB. Obtained vaccination- had vaccine checked by 2 RNs. Vaccine given in the left deltoid IM. Patient immediately complains of belly hurting. Within seconds then begins complaining of seeing spots, begins coughing, and complaining of not being able to breathe. Obtained help from all staff. Immediately obtained pOx of 81% while coughing.  Facial and lip swelling, redness, and facial rash began to occur.  1500- Dr. in  room. Pox 95% on room air. RR 24.  BP 116/70. HR 100. Epi IM 0.37ml given in the left thigh  1505- Benadryl IM 0.74 ML given IM in the right thigh by myself. 1506- Albuterol given via nebulizer. HR 110. RR 30 pOX 98%, BP 104/70.  RR 30.  1510: BP 97/64. HR 108. pOx 97% room air Still unable to obtain accurate RR.  1515: Albuterol completed 97/66 HR 94 Pox 98% on room air.  1520: Pox 98% room air HR 100. RR 24 Pox. BP 101/64.  1525- Per Dr. -EMS to be called for transport to closest ER. Mom aware. Staff RN calling ER to notify.  1531- 104/69  RR 24 Pulse 104.  EMS arrives- vitals prior to EMS hand off- 100/54. HR 110 RR 98% pOx 22. I stayed at patient bedside throughout this event. EMS arrived and Report given to EMS squad by Dr.  Physician to physician report done.  Patient transported to ER for observation period. Per ER note patient remained stable. Was given dose of steroid. Facial swelling improved over time. Patient d/c to home after observation period.
First one didn't work, shingles; Very painful; 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: First one didn't work, shingles) and pain (Verbatim: Very painful). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient have had shingles twice and also had two shots. The first one did not work and then the second more stronger seems to be working. But it was the patient could always get them back and hopefully not. The patient stated that it was very painful. The follow-up could not be possible as no contact details were available.
Pfizer 2nd dose had throat tightness 5 minutes after the shot. No rash but symptoms lasted until prednisone. Pfizer 3rd dose: no immediate reaction, got numbness and tingling down left side of the body then got migraines, got prednisone
Tested positive and had symptoms for Covid-19 .  Admitted to hospital on 2/14/21 in the icu and died in 2/28/21
FOC called 9/2/09. States child had positive adverse Rxn 3 days after vaccination on 8/28/09. Client with rash had spike - no fever 99 to 101 mtn. Relieved Dx MOTRIN and an occasion of febrile sz. FOC states child w/hx of febrile sz at 9 mos. old and follow up w/PMD scheduled for 9/3/09. States went to PMD 9/3 at clinic - Mom states child Ok now 9/5/09 on follow up call.
pt recv vax 6NOV95 & that day devel in inj site rxn characterized by swelling & redness;pt also c/o chills;
Pt, who is 35, born 08/26/1985 rec'd 0.3 mL PFIZER Covid-19 mRNA vaccine Lot EW0171 at 0735 today via IM injection in R deltoid. This was her first dose. At approx 0800 Pt reported feeling "tingles" at the injection site which radiated to the R side of her body. Pt characterized this event as "the same as last time (with an unknown injection)". VSS with BP 165/80, HR 78, SPO2 99%, RR 18. Pt given water and monitored. She reported being allergic to PCN and denied all other allergies. At approx 0815 pt reported the symptoms were worsening. Pt has asthma/reactive airway disease, DM2, and PVCs. She uses albuterol 90 mcg/actuation prn and lasix 20 mg/day prn swelling. When pt reported worsening symptoms a code team alert was called. The team assessed the patient and wheeled her to her MD office at approx 0845.
Handful of men experienced heart inflammation; This serious initial spontaneous safety report was received by Novavax on 15-SEP-2022 from a consumer.  A male of an unspecified age was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual reported that a handful of men experienced heart inflammation (PT: Carditis) (Serious: Medically Significant).  At the time of reporting, the event outcome of Carditis was unknown.  Lot number was not provided in the report.; Sender's Comments: This male of an unspecified age experienced: Carditis after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL.  The event Carditis was reported as serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event was assessed as Possible.
pt recvd vax JUN92 & 1 to 2 days p/vax pt noted local area of redness, swelling & tenderness @ the inject site which became progressively worse; treated for local infect w/gradual resolution of sx over 10 days;
Right anterior thigh with 3 puncture sites. Erythema extending from most inferior and medial injection site. No induration, nontender to palpate.
I began to notice lymph node swelling on the same side as my booster, followed with fatigue and slight headaches. Symptoms have continued to come and go since booster vaccine. I am experiencing being tired and fatigued still as well.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional (office staff). This case involves an adult patient of unknown demographics who was vaccinated with a doses of IPOL, FLUZONE QUADRIVALENT, DAPTACEL and PENTACEL and while treated with TUBERSOL (lot number and expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and poor quality product administered. On 20 Oct 2018, alarm recorded excursion for 8 hours and 5 minutes, reached (-1.5) C. Oct 21st, excursion for 19 hours below 0 C was recorded and on Oct 22nd excursion for 6 hours below 0 C. It was not reported whether the patient experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 09755AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Client's significant other called to say that client had a full body rash.  Rash was red but not angry and not itching. Client was able to breathe with no difficulty.  There were no other issues with client's body (e.g., bruising, hot areas, raised areas) and client was hesitant to go anywhere to have rash tended to.
Severe pain at the injection site for several days with swelling to the lips on the right side of mouth for two consecutive days.
Date of Admission: 9/7/2023   Date of Discharge: 9/8/2023   Issues to be Addressed at Follow-up: Restarting BP meds (he will likely do on his own)   Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   9/8/2023  3:50 PM MRSA SCREENING CULTURE In process NARES   9/7/2023  9:30 PM BODY FLUID CULTURE In process PERITONEAL DIALYSIS FLUID   9/7/2023  2:10 PM BLOOD CULTURE 2 Preliminary BLOOD   9/7/2023  1:50 PM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) COVID-19 DISEASE   ? ESRD ON PERITONEAL DIALYSIS   ? HYPONATREMIA
Janssen COVID-19 Vaccine EUA. Last night I was very warm, had a terrible headache, felt tired/dissociated and my entire body ached. I went to bed around midnight and woke up at 5 with terrible chills, body aches and a headache and couldn't stop shaking and couldn't fall back asleep for about an hour. I woke up around 10 drenched in sweat and had a bad headache, body aches and a 101 fever. I took ibuprofen last night, around 8 this morning at 5 and this morning at 10 and felt slight symptom relief but still have a fever.
limbs paralyzed (arms and legs); leg swelling; extreme tiredness; extreme joint pain in elbows and knees; could hardly walk; muscle pain; she couldn't sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on Sep2021 as single dose for COVID-19 immunization. The patient's medical history included hypertension (She does not have illness except high blood pressure) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient got the tetanus shot on an unspecified date in 2001 and had no reaction to it. On an unspecified date, after first dose patient experienced limbs paralyzed, leg swelling, extreme tiredness, extreme joint pain in elbows and knees, could hardly walk, muscle pain and she couldn't sleep. she still has symptoms and with the aspirin they are not as bad, her friend told her to take some, she hadn't thought to. Patient had it for 2 weeks and she is hoping it goes away. Patient states she was a little afraid and she doesn't take aspirin and her friend told her to take some so last night she took some and it helped a little but the joint pain and muscle pain was still there. Caller relays that the swelling of her leg went down but it still feels uncomfortable. States the swelling is scary they felt like phone poles, big and heavy. Patient felt like she should go to the hospital and it's not supposed to kill you, it was bad severe pain in her muscles and joints and she felt like her limbs were kind of paralyzed. Patient didn't have arm pain or swelling at the injection site or other symptoms like nausea, vomiting or diarrhea but the paralysis, tiredness, muscle and joint pain was overwhelming. Patient states when she went to get a tetanus and something else and her whole life she hasn't needed any and doesn't get sick a lot. Patient asking should she get the 2nd shot. Patients doctor moved out of state and the new doctor she was supposed to meet was out on administrative leave and she got a new physician and sees them 02Nov2021. Therapeutic measures were taken as a result of extreme tiredness, extreme joint pain in elbows and knees and muscle pain. The outcome of the events sleep difficult, could hardly walk, limbs paralyzed (arms and legs) was unknown; muscle pain, extreme joint pain in elbows and knees, leg swelling was not recovered; extreme tiredness was recovered on an unspecified date.
2006 - indecisiveness, not feeling "regular". 2007 - tiredness, extreme sensitivity. 2008 - physical symptoms in arms. 2009 - diagnosed w/ paralysis, severe headaches. 2011 - diagnosed w/ MS after brain MRI. 2013 - reconfirmed MS after brain and spinal MRI's.
Information has been received from a registered nurse concerning a pt who in 1994 was vaccinated with the second dose of hep b vaccine recombinant. One day after the vaccination the pt experienced fatigue, 103 F fever, headache and stomach ache. The pt sought unspecified medical attention. Additional information has been requested.
Site reaction started within 5 minutes, redness and swelling, itchiness; nerve vibrations on and off with left foot (worse with weight-bearing), swelling in left leg w/o heat or redness, worse in left ankle, joint pain, hips, shoulders.  No fever, nausea or vomiting.  Patient contacted primary care doctor as well.
Left arm given Zostavax 09/10/07. Developed small swelling and redness initially at home, erythema got progressively bigger. She had fever when seen at ED on 9/13/07. The erythema and swelling was about 15cm x 10 cm.
Pt vaccinated w/DTP/OPV experienced 1 day of screaming inconsolably afebrile. Also described as having gas.
His daughter was receiving a Hep A vaccine and the needle hub was cracked and it squirted on dad. Dad called 4/30/08 and said he was having shortness of breath since the vaccine was squirted at him.
Within 24 hours, had a temperature of 103F, hives and swollen lips. Taken to ER and received Benadryl and antipyretics.
Left deltoid area swollen, tender and hot to palpation. Unable to move arm or flexion. Fever upt 10 103.0 by history.
Information has been received from a register nurse concerning an approximately 25 year old female who on an unspecified date was vaccinated with 3 doses of RECOMBIVAX HB (therapy dose, route and site unknown). But the patient had not seroconverted. No adverse events reported. Additional information has been requested.
As soon as the vaccine was injected into my arm, I felt a pain that I didn't feel after receiving my first dose. Around the injection site, on the next day, I noticed a lump was forming on my arm. The lump got to the size, in circumference, of a softball. I went to get an allergy shot from my doctor's office and they noticed the lump as well. I was given a prescription for hydrocortisone cream, but it didn't really help. The lump stayed for about a week and went away on it's own.
7hrs after this injection on 1/16 I noticed 2 raised welts about 1.5? diameter below the injection site.  Then on 1/23 I developed severe itching, redness, pain, and the rash spread about 6? in diameter even coming into the area inside the inner part of my bicep. Very uncomfortable due to severe itch.
PATIENT RECEIVED 3 VACCINES ON SAME DAY 11/22/22, HE WENT TO VISIT FAMILY FOR CHRISTMAS AND ENDED UP IN HOSPITAL FOR STROKE ON CHRISTMAS EVE. HE FELT GOOD GETTING THE VACCINES TOGETHER. THE MD'S WERE CONCERNED HE GOT THEM SIMULTANEOUSLY.
The patient received third dose; Taste further diminished with booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Known allergies:sulfonamide abx allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; ATENOLOL; CALCIUM+D3. Vaccination history included: Bnt162b2 (Lot number unknown, Dose:1), for COVID-19 immunization, reaction(s): "Diminished taste"; Bnt162b2 (Lot number unknown, Dose:2), for COVID-19 immunization, reaction(s): "Diminished taste". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "The patient received third dose"; HYPOGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "Taste further diminished with booster". Therapeutic measures were not taken as a result of hypogeusia.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Device date was reported as 22Oct2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Softball size red, raised, itching, local reaction below injection site starting next day after injection and lasting 3 days, no intervention necessary.
Client had Pfizer vaccines for Covid on March 7* and April 7, 2021.   *Client not sure of date for #1 but says it is about a month before #2 and of that date she is certain. Developed Covid symptoms on 9/16/2021: fever, headache, fatigue. Tested PCR + for Covid Reported as a case of breakthrough Covid illness in a previously vaccinated person
got the vaccine on 05Oct2021 (day 0) and did not come for the second dose on day 7, came back on (26Oct2021) for 2nd dose, with no reported adverse event; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (MI) (Reference number- 00829196).  This case involves a female patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] on 05-Oct-2021 (day 0) and did not come for the second dose on day 7, came back on 26-Oct-2021 for 2nd dose (inappropriate schedule of product administration).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Oct-2021 and 26-Oct-2021, the patient received a first dose and second dose of suspect RABIES (HDC) VACCINE respectively, (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate schedule of vaccine administered (latency: seven days).  It was reported "When should her third dose be administered?".  At the time of reporting, no adverse event reported.  The reporter assessed the causal relationship for event with the IMOVAX RABIES as not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
patient received the DTaP-IPV portion of Pentacel, but did not receive the Hib portion/no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received only the dtap-ipv portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the HiB portion.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 08-Jan-2020, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ206AA/U6615AB via unknown route in the left thigh.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nursing administered ROTAVIRUS vaccine for first time to an 11 mth old child. Patient was well on the day of occurrence (10/26/09) and until 11/2/09 when last spoke to parents (MD spoke to parents). MD called parents 11/2/09 - patient remains well since vaccine.