chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After we left the vaccination site I had chills, severe diarrhea, nausea, extreme fatigue, no appetite, dehydration These symptoms went on for five days. I did not eat or drink for five days. I continued with extreme diarrhea and slept most of the time. I had no energy. My blood pressure dropped to 68/39 and was sent to the Emergency Room and immediately admitted.
Achy, Chills, Diarrhea, Malaise following day hives day 4
elevated bp, increased heart rate, dehydration, dizziness, fainting, lasting 2 hours, over 3rd and 4th hours after fluids given and rest symptoms went away
Information has been received from a physician concerning a 73 year old female who on 15-OCT-2007 was vaccinated with ZOSTAVAX.  Four days post vaccination, on 19-OCT-2007; the patient developed a very red, swollen lump at the injection site.  The swelling and redness continued on for the next four weeks.  The patient was prescribed Benadryl and ice; however the patient has continued to contact the physician with the same problem.  At the time of reporting the outcome was unknown.  Additional information has been requested.
Injections (VARIVAX; INFLUENZA) on 11/5/2008.  Am 11/7/2008- redness tenderness warmth at injection site.
right theigh cellulitis vs early abcess vs sterile abcess starting 9 days after immunization.  Treated with antibiotic Keflex
Spoke with patient's mother on 12/7/2021.  She reported that patient's upper right arm has been itchy since receiving vaccine.
18 y/o male had syncopal episode while sitting in chair in post vaccine observation area. Paramedics on site evaluated and treated the patient. Patient states he has a history of passing out after receiving a blood draw in the past, patient also states he does not like needles. Patient denies any complaint related to the vaccine.
pt recv vax 11/97 & 1mo post vax pt became preg;during preg pt devel several viral upper resp tract infect;pt gave birth to full term live born infant. Follow-up information reported that during pregnancy the patient developed "several viral upper respiratory tract infections." The patient's varicella antibody testing resultd showed that the patient was negative for antibodies. The patient gave birth to a full-term liveborn infant. This report is part of the pregnancy registry. This is an amended report. The varicella antibody test was added to the diagnostic test field and the narritive was updated accordingly.
This spontaneous report as received from an office manager, who is also the patient's grandmother, refers to her granddaughter of unknown age. On 22-NOV-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscular in the right arm (lot number and expiry date not provided). On 22-NOV-2013, the patient was administered 3rd dose of GARDASIL on 22-NOV-2013; second dose was administered on 21-OCT-2013. No adverse effects reported by patient. The outcome of was administered 3rd dose of GARDASIL on 22-nov-2013, second dose was administered on 21-oct-2013 and no adverse effects was unknown. The action taken with GARDASIL was not provided. Additional information is not expected.
The reporter indicated that the pt experienced quite impressive screaming for an unknown duration post vax. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur manufacturer of to concomitantly administered vaccines.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster) single (Lot number: CJ3275) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Jun2022 as dose 4 (booster), single (Lot number: FM0173), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Chronic Pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 20Jan2023 to 24Jan2023 for COVID-19 treatment.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective COVID-19 and the suspect drugs cannot be excluded.
shingles, including any and all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 71 year old male patient.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 04-AUG-2016, at age 70, the patient was administered zoster vaccine live (ZOSTAVAX) at a facility (dose, route, and lot # not provided).  As a result of his receipt of zoster vaccine live (ZOSTAVAX), on 28-APR-2017, the patient was caused to suffer shingles, including any and all of its sequelae.  As a result of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages.  The outcome of the shingles was unknown.  Causality assessment was related.  Additional information has been requested.
Severe tinnitus, continues day and night. Unable to sleep and trouble working/concentrating. Headaches.
Hives occurred and have remained beginning the next morning and have continued until today which is now 5 days.  I had a hives with the first dose starting at day three after the injection, but were scattered and came and went for three weeks.  The second dose hives came on faster and I have more just scattered over my body.  I have history of A-fib with correction by ablation.  Since the second vaccine have had occasional abnormal rhythms. No tests or treatment.
Early menstrual cycle, which arrived 3 days earlier than my normal cycle and happened 3 days after my 2nd shot.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 26th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-703461:Master case
Shingles; bright red rash on the abdomen; severe stomach cramps; body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. On 12-Feb-2021, RASH ERYTHEMATOUS (bright red rash on the abdomen) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved and ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) had not resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received on 19-jun-2021, event shingles was added.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported feeling dizzy/lightheaded about 5 minutes after receiving vaccine. After few minutes, patient reported feeling better, and then feeling dizzy/lightheaded again. Ambulance was called to further assess patient. Ambulance then took patient to emergency room (ER).
Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.   7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian  from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX:  Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN.  ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN.  This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.
The patient called on this day and reported a blistering rash on her torso, neck, arms and legs. Described as red and itchy.
Patient called for tele-health visit on 6/28/2021 with symptoms including moderate and worsening cough, wheezing, chills, fever, stuffy nose, sore throat, body aches and pleuritic chest pain. He reported cough onset was 2 days prior and the rest of the symptoms came on over the last 2 days. Patient was tested for COVID-19 and told to follow-up if no improvement or symptoms worsen.  Patient was admitted on 6/29/2021 after presenting to the ER with 3-day symptoms of aches, chills, fever (103.5 on that morning), fatigue, weakness, shortness of breath, cough and diarrhea. He was put on 2L of oxygen, IV fluids, dexamethasone, remdesivir and tocilizumab. He was then discharged on 7/3/2021 after receiving a full course of steroids and remdesivir.  Patient reported back to the ER on 7/11/2021 with continued shortness of breath, weakness and diarrhea. Patient was given azithromycin and lovenox in the ED. He was readmitted and received a second course of remdesivir and tocilizumab, as well as prednisone. Patient was then discharged again on 7/21/2021.
This spontaneous report was received from a male patient of unknown age who on an unknown date was vaccinated with ZOSTAVAX (dose, route, and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient reported that ZOSTAVAX was stored in a syringe for more than 30 minutes prior to administration. No adverse symptoms reported. The outcome of the event was unknown. The event was not related to ZOSTAVAX. Additional information has been requested.
This is non-serious spontaneous case, initially received from a consumer on 13-Feb-2018, concerning 47-year-old female patient. The patient did not have any medical  history and was not taking any medication. On 13-Feb-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number and expiry date: not reported). It was reported that the vaccine was not shaken before administration (considered as drug administration error). On the same day, after vaccine administration, the patient felt like water when needle went in. The patient did not feel like there was water fluid in the injection. The patient did not have pain at the injection site and no other symptoms. The patient's feeling of water immediately went away. The patient had query regarding shaking of the vaccine before administration. The outcome of the event was reported as recovered.
Headache, runny nose, fatigue, body aches, itchy throat, congested, loss of smell, and dizziness.
Fever and rhinorrhea began one day following administration of Typhoid inactivated vaccine (IM) and Pneumococcal-13 valent (PCV 13) IM. Fever peaked at 104.4. Only supportive measures - antipyretics - have been advised. Her physical exam was normal, except for fever.
abnormal EKG; had a very hard heart beat which is sometimes racing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 09:00 (Lot number: EN6206) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 23Feb2021, when the patient was 32 years old, for Covid-19 Immunization.  The following information was reported: ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 20Mar2021, outcome "not recovered", described as "abnormal EKG"; PALPITATIONS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "had a very hard heart beat which is sometimes racing". The events "abnormal ekg" and "had a very hard heart beat which is sometimes racing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) abnormal; sars-cov-2 test: (07Jan2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of electrocardiogram abnormal, palpitations.  Additional information: Therapeutic measures included wearing heart rate monitor & echocardiogram. Prior to the vaccine the patient had no heart issues. The patient now have seen a specialist and may need ablasion surgery. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was Birth control. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I informed the parents immediately of the error when I discovered it and apologized. My clerical staff and I have developed a workaround to this problem by using paper records generated from the original system interface before system2 went live. We are comparing all currently scheduled clients' system2 records with the paper records of IZs and entering IZs that system2 lacks.
Fever 103.4 <12 hrs from vaccine. Abdominal pain. Fatigue >2wks.
Presented with c/o rash, itch, at sight of vaccination L triceps area.  States feeling hot/cold, yesterday.  Onset noticed about 11pm, 9/25, reaction larger when seen at clinic 2:30pm, 9/26. raised erythematous area L triceps, 50X60 mm. No pox noted, no body rash. T-98.5, no respiratory symptoms. Top hydrocortisone 1% applied.  Suggest oral benadryl 25mg, or try tylenol or advil to help decrease symptoms. Call if increase in symptoms, return to clinic 9/28 to recheck
Within 24 hr. of vaccine, pt. stated feeling dizzy and nauseous, and having a fever for 48 hr.  Within 72 hr. of vaccine pt. stated to having a lump at the vaccine site and is still present.
This spontaneous report as received from a registered nurse, refers to 2 patients of unknown age and gender. Between 09-JUN-2015 and 10-JUN-2015, GARDASIL (lot: K007828; expiration date: 02-MAR-2017 and lot: K008213; expiration date: 17-DEC-2016) was improperly exposed to 20 F for 15 hours. Then, after this on 10-JUN-2015, 2 patients each received a dose of this improperly stored GARDASIL (intramuscularly, dose not reported). It was unspecified which patient received which lot. No known adverse effects. Additional information has been requested.
first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days; first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days; This is a spontaneous report from a contactable physician (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received both of the Pfizer Covid19 vaccine doses, 3 weeks apart. He stated the first injection caused arm and shoulder pain (in the arm that was injected) for about 2 days. The outcome of the events was recovered on unspecified date. The second injection did not cause any adverse events. He felt fine and does not wish to be further contacted.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Dose administered too soon  Narrative:  Prior to vaccine administration, vaccinator could have reviewed  date first dose of vaccine was administered on vaccine record card or computerized patient record and confirmed that it had been 28 days since first dose received.
Very bad aching starting in left arm, from time of vaccine and then continued through entire body; became severe as of 6 hours after vaccine; ended 28 hours after vaccine.  Fever of 101.4 as of 9 hours after vaccine.  Fever lowered to 100.6 at 13 hours after vaccine and stayed at 100.6 until 28 hours after vaccine.  Shivering and chills lasted for 4 hours from 9 hours to 13 hours after vaccine.  Headache began at 15 hours after vaccine and lasted until 28 hours after vaccine.  Nausea began at 13 hours vaccine and lasted on and off until 28 hours after vaccine.  All symptoms ended 28 hours after vaccine.
Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat felt like it was slightly swollen, chills, head felt foggy, instant fatigue
Antibody test negative; inappropriate schedule of drug administration. Information has been received from a health professional concerning a 34 year old female who was vaccinated with a first and second dose of varicella virus vaccine live (Oka/Merck) in April 2002 and in June 2003 respectively. Subsequently the patient did not seroconvert according to an antibody titer. Medical attention was not sought. There was no product quality complaint involved.
I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.