chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sick from 1st shingles shot; 102.4 fever; aches; chills; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult 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, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, pain and chills. On an unknown date, the outcome of the sickness, fever, pain and chills were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, pain and chills to be related to Shingles vaccine.   Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had received first dose of Shingles vaccine and experienced sickness, fever, chills and pain. The patient's body temperature was found to be 102.4 degree Celsius. The patient had also received second dose of shingles vaccine and it was fine.
Resident received 2 doses of Pfizer COVID vaccine on 1/12/21 and 2/2/21. Resident also received 2 doses of Moderna vaccine on 4/1/21 and 4/29/21. No apparent issues,
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were not reported. On 12-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, lot # L000450, expiration date 09-MAR-2016, in the left arm (dose and route was not reported). No co-suspect and concomitant therapies were reported. In April 2015, "on or two days later" of vaccination, the patient experienced redness and swelling at injection site. The patient sought medical attention, called the pharmacist. The outcome of injection site swelling and injection site erythema was reported as recovering. No treatment was given for the adverse events. The causality was not reported. Additional information has been requested.
Case number PHEH2014US025330, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 21-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 20 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry date: Mar 2015) intramuscularly into left deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error.
MD contacted the health center on 3 Jan 08 re a pt who had a large local reaction to AVA #2.  He stated that during the first wk there was a 15 cm area of induration with erythema, then it started to subside.  At day 9 the area reblossomed with an induration, tenderness and on day 11 he was started on antibiotics.  Currently he is feeling better but does report occasional headaches.  Symptom: Edema at injection site, <30 mm; start: 12/29/2007.  Symptom: Headache, general; start: 12/2007.
on 2OCT92 pt cried for 2-3 rhs @ a time when stopped crying was very fussy; adm to hosp;
Headache, Diarrhea, left arm numbness to pibky and ring finger Narrative:
Shrill screaming/crying all day following #2DTP; Taken to ER that evening; no tx advised no more Pertussis;
About 15 minutes after the shot it felt like the right side of my throat was closing. It lasted about 4-5 hours and was not severe.
03/07/22 presents to ED for "shortness of breath". PMHx of "diabetes, ESRD on dialysis, coronary disease and MI, and tracheal stenosis status post multiple tracheal dilations"
HAD SHINGLES,AFTER GETTING THE VACCINES FOR THE SHINGLES/suspected vaccination failure; SHINGLES ON RIGHT HAND SIDE OF CHEST, RIGHT BREAST; LIKED REAL BAD SUNBURN; VERY PAINFUL; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sunburn and pain. On an unknown date, the outcome of the vaccination failure, shingles, sunburn and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sunburn and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-Mar-2023. Reporters Comment: This case was reported by a consumer via interactive digital media. Patient had shingles up on right hand side of chest and down around right breast about 6 month ago it was liked real bad sunburn, very painful. Additional Supportive Information:This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vaccination site pain, Fatigue and Pain (Sore Arm).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
COVID Vaccine Clinic  Upon staff member receiving second dose of vaccination, team took staff member back to vestibule area for injection (proactive)due to previous reaction to first dose. Staff member was positioned supine on cart for injection.  Within 5 minutes, staff member felt dizzy and became nauseated. Blood pressure 119/81 HR 90.Po2 at 100% on room air. Still complained of feeling faint and dizzy. Staff member remained supine and was monitored until symptoms subsided. 1550 Staff member was feeling much better. Symptoms gone per staff member.  Staff member ambulated independently without dizziness.  Staff member went home with husband in stable condition.  Staff member encouraged to contact PCP for any further concerns.   Staff member was evaluated in ED.  fluids given, Zofran for nausea and Benadryl.  CTOH was completed and resulted as no abnormalities.  Staff member was discharged to home in stable condition.
very lethargic; joints on the left side of her body (fingers, elbow, arm) were painful; joints on the left side of her body (fingers, elbow, arm) were swollen; finger pain/arm pain; could barely get out of bed for 3 days; This case was reported by a consumer via sales rep and described the occurrence of lethargy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Twinrix. On an unknown date, 1 day after receiving Shingrix and Twinrix, the patient experienced lethargy, mobility decreased, joint pain, swollen joints and pain in fingers. On an unknown date, the outcome of the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers were recovered/resolved.   The reporter considered the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers to be related to Shingrix. It was unknown if the reporter considered the lethargy, mobility decreased, joint pain, swollen joints and pain in fingers to be related to Twinrix.  Additional details were provided as follows: In 2019 about 6 months ago, the patient received her second dose of Twinrix in her right arm and her first dose of Shingrix in her left arm. The patient woke up the morning very lethargic and could barely get out of bed for 3 days. The day after vaccination the joints on the left side of her body (fingers, elbow, arm) were very painful and swollen.  This progressed only on the left side of the body over a few days and would cause pain even while sleeping.  The patient started on an anti-inflammatory type diet to see if that would help.  The events took a few months to resolve but has fully resolved.  The patient believed that this reaction was due to the Shingrix and has refused to get the second dose of the vaccine. The patient received her 3rd dose of Twinrix without issue or adverse event. The reporter consented to follow up.
Patient received 2nd dose of Rotateq on 10/27/08.  Pt has diarrhea x 10 days, watery stool 3-4x/days.
Fever 100F-102F, body aches and malaise for 3 days. Recovered on 12/11/00.
This spontaneous report as received from a Register Nurse refers to a 10 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 03-OCT-2014, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Arrived with cough, SOB, increased O2 needs. + COVID at urgent care day prior. Dx with COVID pna in ER. Received O2, steroids, zinc, singulair, remdesivir x2 days. DC home on normal O2 requirements.
pt recvd vax 24SEP93 & was adm to hosp on 15NOV93 w/a 2 day history of atypical chest pain; PE did not have a pericardial friction rub, but EKG showed sl elevation in the inferior & lateral leads; reporter states viral pericarditis not r/o
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sore throat; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first vaccine and is scheduled to have second vaccine tomorrow and has sore throat and is taking Robitussin. Wanted to know if they should go and have the vaccine or not. Therapeutic measures were taken as a result of sore throat. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills; fever; Shivering; injection site was quite swollen; Hurts; Very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia, Kidney infection (from childhood) and Overweight.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE WARMTH (Very hot). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering). At the time of the report, VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: Positive.     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.   Concomitant medications provided by the reporter included medications for pre-existing medical conditions. Treatment for the events chills,fever and shivering included Tylenol.
Muscle pain; joint pain; headaches; mild fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Patient had no other medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 00:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  Concomitant medications included ibuprofen sodium (IBUPROFEN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 07:00,  the patient experienced muscle pain, joint pain, headaches, mild fever up to 37.2 centigrade for 11 days after the second shot. Pain in knee joints and leg muscles was still persistent 14 days after the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events of muscle pain and joint pain which included treatment with ibuprofen 400mg (2x per day) to sooth the pain. On 14Apr2021, 12th day after the second shot, the patient underwent erythrocyte sedimentation rate by modified westergren and the result was 43 mm/h (norm is <OR = 15) and the C- reactive protein test was also done and the result was 53.7 mg/l (norm is <8.0 mg/L). On 03Apr2021, the patient underwent body temperature  check and the result was 37.2 centigrade.  Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events of muscle pain and  joint pain was recovering while events of  headaches, mild fever was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected
After Rotateq developed abdominal pain, diarrhea, dusky lips and extremities, pallor, fussiness, hoarseness, increase heart rate and nasal congestion and fever and cough and heme (+) stool,
2" x 4" raised, red, indurated, itchy, warm to touch, welt at injection site.
On the first day of receiving the booster dose of Moderna on 12/21/21 I had a sore arm, fatigue , headache, and  heart palpitations.
sz manifested by nystagmoid eye movement to rt w/low grade fever of 100.8; febrile sz;
Pt. states that after receiving the 3rd dose of Moderna 12/08/2021, started experiencing symptoms 12/10/2021 of redness in the left arm, swelling upper left arm, and high pulse rate (100's).  Hospital Emergency Room visit 12/11/2021, Blood Work, prescribed Antibiotic (diagnosed injection site redness due to Infection). Cardiologist communications 12/14/2021 (waiting for recommendations). Still experiencing symptoms.
Nasal congestion and joint pain in evening of 9-20-10.  Joint aches worsened and had 2 days off work. Worked 9-27-10 but felt more congested and continued with joint pain. Appointment with her PCP 9-28-10 was given Prednisone and off work for day. Diagnosed Acute reaction to vaccine.
joint/muscle pain; Severe weakness; chills; joint/muscle pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: EN6207, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 11Mar2021 at 11:00 (age at vaccination 77-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included diabetes, heart disease, parkinson's disease and allergies to latex from an unknown date and unknown if ongoing. The patient previously took morphine and cyclosporine and experienced drug hypersensitivity. Concomitant medications were not reported. The patient had known allergies. The patient was tested positive for COVID-19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior and patient was on other medications 2 weeks prior to the COVID vaccine. On 12Mar2021 at 12:00, the patient experienced severe weakness, chills, joint pain and muscle pain on an unspecified date. No treatment was received as a result of events. The outcome of the event muscle pain was unknown and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerns a 76-year-old, elderly male patient. The patient's medical history and concomitant medications were not reported. On 24-Sep-2018, the suspect vaccine was left in the cooler that reached the temperature of 34.4 F, which was out of the recommended temperature range for 45 minutes. The average of the incident was about 35.4 F for a period for 35 minutes (explicitly coded as incorrect product storage). On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) that underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. The reporter assessed this case as non-serious. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed the date of temperature excursion and vaccine administration (24-Sep-2018). The narrative was amended accordingly.
Dizziness; Weakness; Sweating; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (booster), single (Lot number: BH9694) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 22Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3597), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient got paxlovid from 23May2023 to 28May2023 as COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300210389 same reporter/patient, different product/ event.;
after vaccination, patient became pale and also reported feeling light headed,  and briefly passed out. She did not loss consciousness
about 1/2 h after receiving his IZ while still at the office patient showed called me to the room due to red dots on his palms.   I examined his skin from head to soles of his feet. Only skin finding was blanching fine erythematous macule on both palms. No raised lesions. No tenderness or swelling. He did not c/o itchiness or pain and had no tenderness to area.   I asked him to stay in office for observation. Rechecked 7 minutes later and rash was less red. Checked again at 15 minutes and rash had almost completely resolved. He developed no other symptoms. He was allowed to leave with staff member from the facility who I informed of rash and resolution. Advised to seek care if rash returned. Emergent care in unlikely event of SOB,lethargy, hives.
Pt reports approximately 90 minutes after receiving the injection that she began to feel short of breath, dizzy, and had a slight h/a (dull, 2-3/10). BP 136/79, HR 88, RR 24, O2 Sat 97%.
Patient received vaccine 9/6/23 in the morning then had sore arm by 9/7/23 she noticed rash on arm at the injection site that spread to her whole body. patient went to her primary care doctor who gave her a steroid shot.
Systemic hives lasting 6 weeks, including swollen eyes, lips, face. Used Claritin and Benadryl to offset side effects throughout 6 weeks.
Pt called pharmacy on Sat May 18th reporting large area of redness surrounding the area of vaccination.  Pt came in May 21 st stating that the arm became painful Monday the 20 th.  I examined the area and found a bruise at injection site and an area of 7 inches by 7 inches below that had a 4 x 4 in white area and the remaining area was all red and warm to the touch. After calling Glaxo I sent patient to Urgent Care for further evaluation as pt seemed anxious about the situation.