chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got first injection 15Sep2021 and had the "mother" of all flares.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Sep2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Have DX of fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: FIBROMYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Got first injection 15Sep2021 and had the "mother" of all flares.". Therapeutic measures were not taken as a result of fibromyalgia.  Additional Information: Have DX of fibromyalgia. Got first injection 15Sep2021 and had the "mother" of all flares. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had not resolved.            No concomitant medications were mentioned. No treatment details were reported.
"3 hours after receiving his first dose he vomited violently. He then vomited every hour for the next 9 hours"; "also had diarrhea"; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to seasonal hay fever and sulfa drugs. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 20:30, 3 hours after receiving the first dose, the patient vomited violently. The patient then vomited every hour for the next 9 hours, and also had diarrhoea. The patient had not been vomiting now (at the time of this report) for the past 8 hours but his diarrhoea continued. The vomiting was so severe that they were encouraged to bring him to the hospital, but did not do so (as reported). The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "3 hours after receiving his first dose he vomited violently. He then vomited every hour for the next 9 hours" and "also had diarrhea" were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccinated 12/17/20 Last known positive exposure 12/19/20 Symptoms started 12/26/20  Symptoms: chills, shortness of breath, raging headache, nausea, congestion, body aches, fatigue, tightness of chest.
approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of bed safely. I have never experienced a chill like this before. 3-4am I was shivering and shaking and so very cold again. this lasted until at least 4-5pm. I was shaky and my voice was shaky. no appetite.
Mild Fever; soreness at the site of the injection; Vaccine administered to 17 yr old; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever), VACCINATION SITE PAIN (soreness at the site of the injection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 yr old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included 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) at an unspecified dose and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PYREXIA (Mild Fever), VACCINATION SITE PAIN (soreness at the site of the injection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17 yr old). At the time of the report, PYREXIA (Mild Fever) outcome was unknown. Not Provided          This case was linked to MOD-2021-076412 (Patient Link).
Starting the evening after receiving the vaccine, I had a sore arm and fatigue. For the next two days, I ended up calling out because I was so tired. Then a few weeks later I developed a Psoriasis flare up on both elbows and the back of my hair line. I self treated it with the topical steroids and by the time I got the second dose I felt like it had calmed down.
injection arm extremely sore; Body Aches; chills; Voice became scratchy/Voice hoarseness progressing from littele to very hoarsing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice became scratchy/Voice hoarseness progressing from littele to very hoarsing), VACCINATION SITE PAIN (injection arm extremely sore), MYALGIA (Body Aches) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DYSPHONIA (Voice became scratchy/Voice hoarseness progressing from littele to very hoarsing). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection arm extremely sore), MYALGIA (Body Aches) and CHILLS (chills). On 09-Feb-2021, DYSPHONIA (Voice became scratchy/Voice hoarseness progressing from littele to very hoarsing) had resolved. At the time of the report, VACCINATION SITE PAIN (injection arm extremely sore), MYALGIA (Body Aches) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment of these events were reported.   This case was linked to MOD-2021-239296 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Update new dose-1 event and dose-2 information. On 02-Aug-2021: Non-Significant Follow-up, Reporter's contact details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
C/O nausea, diffuse diarrhea, headache, and posterior neck pain, chills and fever from day following vaccine to at lease 5 days later when reported.
Pt described symptoms developing 2 days after vaccination of swelling, pain, itching, tenderness and warmth at injection site. Pt reported feeling lethargic and tired No fever or headache. Patient saw Dr at scheduled appt.
Pt recv vax on 12/2/98; on 12/5/98 pt exp pain when lifting LA, tricep area swollen, red, hot; tx=ice & Ibuprofen
Sneezing, coughing, nasal congestion, fever 98.9, disrupted sleep.
The patient was given the dose for a 5-11 year old,   not a 13 year old
approx 4-5 hours after vaccine I began to have burning on the soles of my feet when I walked. It felt like I was walking on hot coals. This continued in both feet for approx 24 hours. It never went away completely in the R foot. My right foot continues to have burning pain, inflammation, and occasional numbness in my toes. It is more localized to plantar fasciitis area now. I have had a cortisone shot, muscle rub salve, anti-inflammatories with no relief in R foot. I have another podiatry appt tomorrow and an appt with neurologist on Thurs. PCP and podiatrist said they think it may be an inflammatory response to the vaccine that irritated something that was "already brewing" in that area.
Starting at approximately 2200 hours noticed ringing in right ear, stuffy feeling in both ears. Continued through out the night. Next morning at 0730 hours upon awaking louder ring in right ear and lower ringing in left ear with swelling feeling in both ears. Nasal passages feel clear, no drainage, no other S/S.
Pt had fever 36 hours after vaccines given and presented to ER. Septic workup negative, sent home and subsequently admitted 09-04-09 for fever and fussiness. Noted to develop pancytopenia and increased LFT during hospitalization. Increased Ferritin.
Two vaccines (MENACTRA and STAMARIL) were administered on the same day in different arms. MENACTRA was administered by mistake subcutaneously rather than IM.  As a result, induration of the subcutaneous tissue on the left arm (site of MENACTRA vaccine) occurred ~24-36 hours after vaccine.
Amenorrhea (no period) x 3 1/2 + months (ongoing) in non sexually active pt given GARDASIL vaccine.
Really really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Really really sick) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really really sick). At the time of the report, ILLNESS (Really really sick) outcome was unknown.        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 concomitant medications were provided. Treatment information was not provided.  Reporter/patient's spouse was a lead pharmacy technician. She did not have the vaccination card at the time of reporting and mentioned the date of vaccination as 23-Dec-2021.   This case was linked to MOD-2021-291688 .
This spontaneous report as received from a nurse refers to a patient of unknown age. On 28-MAY-2008 the patient was vaccinated with the first dose of VAQTA (dose, route, frequency, lot# and expiration date were unknown). On 21-NOV-2008 the patient was vaccine with the second dose of VAQTA (25U/0.5ml, dose, route, frequency, lot# and expiration date were unknown). No adverse symptoms reported. Additional information has been requested.
Hiberix non approved diluent/reconstituted with an MMR vaccine diluent; Hiberix non approved diluent/reconstituted with an MMR vaccine diluent; 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 2-month-old male patient who received Hib (Hiberix) (batch number D5B5G, expiry date 24-FEB-2024) for prophylaxis.   On 27-MAR-2023, the patient received Hiberix. On 27-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix non approved diluent/reconstituted with an MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: Hiberix non approved diluent/reconstituted with an MMR vaccine diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter reported that the patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent. The vaccine administration facility was the same as primary reporter. No more information was provided about the diluent used in reconstitution of vaccine. The reporter consented to follow up via email. The patient received Hiberix vaccine which was reconstituted with an MMR vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered This case had been linked with US2023063927, reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2023063927:Same reporter/Other patient
Severe/debilitating pain in right arm, possible flare of autoimmune disorder including severe all-over joint and muscular pain with joint swelling that Advil is not eliminating, chills, fatigue
patient aged 17 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Apr-2021 at 1:11 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 1:11 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a health professional concerning a 60 year old white male with no drug reactions/allergies and no illness at the time of vaccination who on 16-JAN-2008 at 10:30 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 658493/0991U) subcutaneous in the left arm. On 17-JAN-2008 at 8 AM, the patient experienced swelling at the vaccine site, redness, tenderness, was hard to the touch, had pain shooting down to the forearm, was sensitive and had a warm feeling. On 28-JAN-2008, the patient recovered from all the events. Additional information is not expected.
Patient received vaccine on 1/13/21; started having headaches on 1/13/21 in the evening. On 1/14/21 developed chills, body aches and nausea. On 1/15/21 had chills, body aches, nausea and fevers as high as 102.0F - also developed lump in left neck on 1/15. Starting on 1/16/21 he noted pain radiating from left deltoid to left hand digits - specifically the 4th digit, palmar surface. Symptoms began improving on 1/17/21 and on that day he mainly felt just soreness in his left arm. On 1/18/21 he noticed the lump in the left neck was still present and he had tightness in the left triceps region.
Hives, all over itchy.  Took Benadryl was fine by evening.
expired dose of tenivac was administered to a patient, with no reported adverse event; Initial information received  on 14-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 56 years old male patient who received expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received 0.5 ml dose (total) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids NO Preservative Adult Suspension for injection lot U6922AA and expiry: 22-Jan-2023 via intramuscular route in the right deltoid for immunization.   On 14-Mar-2023, the patient developed a non-serious event expired dose of tenivac was administered to a patient, with no reported adverse event (expired product administered) same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of tenivac was administered to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered to a patient, with no reported adverse 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 guidelines. 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.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received RABAVERT. Co-suspect products IMOVAX RABBIA. Concurrent medical conditions included knee pain (due to old injuries) and pain in elbow. On 3rd August 2017, the patient received the 1st dose of RABAVERT. On 7th August 2017, the patient received the 2nd dose of IMOVAX RABBIA. In August 2017, less than a week after receiving RABAVERT, the patient experienced diarrhea, general body pain, pain in arm, arthralgia, eye pain and interchange of vaccine products. In August 2017, the outcome of the diarrhea, general body pain, pain in arm, arthralgia and eye pain were recovered/resolved. On an unknown date, the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the diarrhea, general body pain, pain in arm, arthralgia and eye pain to be related to RABAVERT. Additional details were provided as follows: The patient noted that she was a small frame and stature. She declined any other personal demographics. The age at vaccination was not reported. The patient declined any other personal demographics. After vaccination, the patient experienced diarrhea, body ache, pain with old injuries exacerbated (knee and elbow pain) and eye pain. These issues were resolved after the second day. On 7th August 2017, at an urgent care, the patient received IMOVAX as her second dose of rabies vaccine, which led to interchange of vaccine products. Less than a month after IMOVAX, the patient experienced fever, tiredness, eye pain, arm pain and leg weakness. She stated, the issues appeared to be worse than with the first dose (RABAVERT). The patient did not receive any other doses and was not sure how to proceed. The patient was referred to her physician or the initial Emergency room physician where she received the RABAVERT. The patient noted that she had pain in her left arm, but that was opposite the side of the potential bite and immunizations. The patient was also referred to the Centers for Disease Control and Prevention (CDC) for direction. The patient reported that she had eye pain with both vaccines. The patient had denied permission to contact their physician.
2nd shot 7 months after the 1st; This case was reported by a consumer via media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 7 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: Case was reported by patient himself/herself. Age at vaccination was not provided. The patient received the 2nd dose of shingles vaccine almost after 7 months, which led to lengthening of vaccination schedule. The patient enquired if it was ok if he/she received the 2nd dose after 7 months. Follow-up would not be possible as no contact details provided.
Approx. 1/2 hr after immunization given, pt noticed slight nausea.  At 5:25 PM she became very nauseated + vomited small amt.  TPR 99 degrees F - 74  20 BP 137/98.  Clammy, c/o feeling hot.  After several min. felt better but became nauseated again approx. 20 min. later + vomited large amt.  Pt called for a ride + was sent home.
Aggressive Cough; Shortness of breath; Chest Pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (Chest Pain), COUGH (Aggressive Cough), HEADACHE (Headache) and FATIGUE (Fatigue) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 04-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath) and CHEST PAIN (Chest Pain). On 05-Feb-2021, the patient experienced COUGH (Aggressive Cough). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (Chest Pain), COUGH (Aggressive Cough), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Information has been received from a physicians assistant concerning a 13-month-old black male with allergic rhinitis and no pertinent medical history who on 05-JUN-2007 (16:00) was vaccinated in his left thigh with his first 0.5ml dose of PROQUAD (Lot # "02266"). On 15-JUN-2007 after getting vaccinated with PROQUAD, the patient developed a measles like rash over the whole body, fever and irritability. The rash was further described as diffuse maculopapular rash which was measles like. No further information was provided. unspecified medical attention was sought during which a "strep" diagnostic lab was performed and the results were negative. No product quality complaint was involved. Follow-up information was received on 05-SEP-2007 and the previous narrative was updated to reflect exact time and date of vaccination, start date of the adverse experiences, and demographic information. The patient's status was updated to recovered for all adverse events except irritability. Additional information is not expected.
Severe headache  High fever 101 Severe aches   All lasting approximately 24 hours.
Patient became light headed and laid down after the vaccination. After about 10 minutes, the patient sat up and became itchy.  The patient then described her throat as being itchy and swollen while having trouble breathing.  Emergency personnel were called and an Epi-Pen was then injected to the  patient. Shortly afterward, patient said her throat was feeling clear and could breathe again. Patient was transported to local hospital for further evaluation.