chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, Headache, Dizziness, Fever, Hives, Vomiting, Diarrhea, Prickly under my skin
Received the 2nd dose of Pfizer, 16 days after 1st dose of Pfizer administered. 1st dose of Pfizer administered on 10/14/21.
Onset of erythema and edema at injection site within 24-48 hrs of vaccine. About 48 hrs 10x12 cm area of erythema and induration.
Vaccine administered after it was stored at room temperature for 18 hours; Vaccine administered after it was stored at room temperature for 18 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours). On 15-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours) had resolved.        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.   No concomitant medications were reported. No treatment information was provided.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 78-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medications included METOPROLOL, NITROGLYCERIN, SIMVASTATIN, NEPHRO-VITE, RANITIDINE, RENAGEL, PROPOXY-N, and APAP.  On 1 February 2008 the subject received two doses of ENGERIX B at 20 mcg, one in each arm.  This was considered to be the 3rd adult dosage of ENGERIX B for this subject.  This subject received two doses at 20 mcg each.  On 6 February 2008, 5 days after vaccination with ENGERIX B, the subject was tested and found to be hepatitis B antigen positive.  The office was assuming the results of the hepatitis antigen was a false positive.  At the time of reporting the outcome of positive hepatitis B antigen was unknown.  Follow-up information was received from the healthcare professional on 13 March 2008.  On 15 February 2008, the subject was tested and found to be hepatitis B antigen negative.  The events resolved on 15 February 2008.  The healthcare professional considered the events were related to vaccination with ENGERIX B.  The immunization series with ENGERIX B was not delayed or discontinued.
pt recvd vax;17oct94 in eve shift very sleepy;18oct no t, BP 102/80; c/o hurting all over; fine crackles both lung fields,cont thru eve, fine crackles lt mid, lower lobe; 19oct 4pm, lungs clear;
Received 3rd booster. States a few days after, right leg was swollen with pain. Diagnosed with Right acute DVT.
With 17X 2cm erythematous area with mild edema on (L) triceps/biceps region extending to elbow x 3days- Pt Rx ALLEGRA and Naproxen.
Client received Tdap without any symptoms of concern. Then, immediately after HPV vaccine was given, the client complained that her arm hurt. She turned her head away and when I checked on her(within seconds), her upper body stiffened and her head and arms started shaking. She was very pale. Shaking lasted 15-30 seconds, then her eyes were opened very wide and she seemed to be aware that something had just happened.  She did not complain of dizziness, nausea, discomfort other than her right arm, headache or any other symptoms.  Vitals lying down - 10:20 am: BP 118/70, pulse 88; 10:23 am BP 122/74, Pulse 64, Resp 14; 10:38 am BP 118/60, pulse 76; 10:46 am BP 108/68, resp. 20,pulse 80, temp 98.4. Vitals sitting upright - 10:53 am BP 110/70; pulse 76; 11:02 BP 118/40, Pulse 68, Resp. 16.  Client was given Tylenol, peanut butter crackers and orange juice and reported feeling much better.  Telephone messages left for parent.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick a day and a half) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. Concomitant products included ENALAPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, ERGOCALCIFEROL (VITAMIN D2) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick a day and a half). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (felt sick a day and a half) had resolved. 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.Concomitant includes vitamins.This case was linked to MOD-2022-453539, MOD-2022-453540 (Patient Link).
Day after administration, painful and hot; 2 days after administration, pain lessened but pt now has a rash starting below the site of administration down to elbow and about 2/3 arm circumference, rash not painful or itchy but is still hot, patient has marked the extremities of the rash and will monitor for rash expansion and will follow up with PCP if that occurs, patient will return to follow up with us.
Pt recvd MMR vax 13JUL90; On 17JUL90 pt devel encephalitis w/fever, sleepiness, & loss of balance; The following day unsteady gait & loss of balance persisted, & was hospitalized for observation overnight; Pt recovered;
ABDOMINAL PAIN,SOI LF DEL 1 cm ECCHYMOSIS,FEVER,HEADACHES,MESENTERIC ADENITIS,MYALGIAS,NECK STIFF,EPIGASTRIC PAIN,SHAKING,CHILLS,POSSIBLE FLU,POSS REACTION TO HEP VAX. ENGERIX-B GIVEN ON 12-FEB-90 AND 12-MAR-90. FURTHER DETAILS ON WORM.
have very low IgG (374); My concern is I did not make any antibody because I don't have any; This is a spontaneous report from a contactable physician (the patient).  This 73 year-old male patient received the first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, both for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia.  The patient's concomitant medications were not reported. The patient reported, "I received both Pfizer vaccines 19 days apart, waited a month and got a spike protein antibody test. I have very low IgG (374), when I got my series of Hep B 3 injections I had 0 antibodies. He stated "I see now your vaccine is now effective with variants. My concern is I did not make any antibody, because I don't have any. My concern is my low IgG". The patient had lab tests and procedures in Feb2021 which included antibody test: negative, "I had 0 antibodies", blood immunoglobulin G: 374, very low. The clinical outcome of the events was unknown.   Information on the lot number has been requested.
The right arm was tender, sore, red and painful. Within the next couple of days the discomfort traveled down her arm to her elbow and the elbow corner swelled up as if there was fluid in it and was red and painful. She went to see her internist and he thought that it could possibly be infected because it was red and swollen so he prescribed doxycycline and cephalexin. The pain level and swelling came down but is not completely gone.
Developed fever of 102 after 2 days with aching arm and shoulder pain with diminished movement. No getting better even after 2 1/2 weeks.
Swelling & stiffness in arm @ injection site. 01/08/2013 numbness in feet. 01/15/2013 numbness/tingling in feet, hands. 01/21/2013 burning sensation through shoulders, neck pain. 01/24/2013 symptoms continue, losing mobility in hands. 01/26/2013 symptoms continue, barely able to walk. 01/28/2013 Dr appt, muscle relaxers prescribed 01/29/2013 fall, unable to walk. 01/30/2013 Dr appt, carried to car, ER, hospitalization. Diagnosis- GBS Guillain-Barré syndrome. In the days/weeks following hospitalization: spinal tap, paralysis, plasma TPE, tracheotomy, ICU, code blue-resuscitation. 02/26/2013 transferred to another hospital, start of rehabilitation. Several weeks later massive blood clot in left leg. Made choice to leave hospital on 03/30/2013, due to no health insurance and the financial burden this was putting on my family.
extremely sleepy; Dizzy; tightness in chest; bad arm pain; bad shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain). At the time of the report, SOMNOLENCE (extremely sleepy), DIZZINESS (Dizzy), CHEST DISCOMFORT (tightness in chest), MYALGIA (bad arm pain) and ARTHRALGIA (bad shoulder pain) outcome was unknown.            Reporter did not allow further contact
Covid Arm (redness, itchiness, warmth and swelling)  in a circular area around the injection site.
received 1st dose on 1/22/21 at 3:45 PM.   On 1/23/21 I developed muscle pain, severe headache, fever of 102.00 , extreme sleepiness, chills and stuffy nose.   This continued through 1/25/21.  On 1/26/21 these symptoms subsided.
after admisnitering the vaccine within 3 min, the client complainted of  both eyes itching and tingling under both eyes. The client was given Benadryl 12.5mg po at 9:53am. client stayed until 10:10am and stated that he felt better that his eyes were much better  and less of the itching and tinglling in both eyes. Client informed to take more benadyl if need in 6 hours and to call EMS  if symtoms worsen. Client verbalized understanding.
patient received an expired dose of IPOL, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number-00704258) and transmitted to Sanofi on 30-Jul-2021.  This case involves patient of unknown demographics who received an expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information on concomitant medications was not reported.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number: P1F541M; expiry date: 12-Jul-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "caller stated a patient received an expired IPOL vaccine and wanted to know what to do from here. The caller reported that this vaccine was from the state supplied vaccines that he does not monitor at this time and that patient Information, complete event Information, and Administering physician are unknown to the caller."  No adverse events were 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.
Intractable migraine; Head pain; Heart rate gets extremely high; almost passed out; Nauseated; Vomit; I have not been able to function normally in 6 weeks; Fevers off and on; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 15Apr2021 10:00 (at the age of 32 years old) (lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included endometriosis, asthma, known allergies to IV contrast dye. No Covid prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); ondansetron (ZOFRAN). The patient previously took chlorhexidine gluconate / isopropanol (CHLORAPREP) and experienced allergies, doxycycline and experienced allergies, cefalexin monohydrate (KEFLEX) and experienced allergies, received the first dose of bnt162b2 on 24Mar2021 10:00 at the age of 32 years old for COVID-19 immunization. An intractable migraine began after receiving her second dose of the vaccine. She had not struggled with migraine until the second dose of the vaccine. Less than a week after the vaccine, her migraine was still so bad she sought emergent treatment at the hospital emergency room. She underwent several invasive tests before neurology narrowed down the cause to her vaccine. It has now been 46 days and she have been hospitalized 3 times and her head pain has not abated. None of the usual medications for migraine work. It was so bad that her heart rate got extremely high, she saw black. She almost passed out. She was nauseated and vomited. She had not been able to function normally in 6 weeks. She got fevers off and on. Adverse events start date was 15Apr2021 13:00. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Duration of hospitalization was 9 days. The patient underwent lab tests and procedures, which included Nasal Swab: Negative on 27May2021. Therapeutic measures were taken as a result of events and included treatment with nerve block injections, steroids, DHE, seizure med. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only.
Increased number of firm, itchy lesions, low grade temp. Tx: Tylenol, Benadryl. ? Varicella
Child care provider reported that child had varicella after receiving varicella vaccine on 5/2/05. Had fever 5/9/05 and extensive rash starting 5/11/05. Child also had MMR vaccine same date. Child brought to health clinic. No vesicles noted. On rash exam, mother looked at pustules and stated rash looked like rubeola example.
This spontaneous report was received from a pharmacist referring to an 18 year old male patient. Information on his pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in July 2017 (at the age of 17), the patient was vaccinated with first dose of GARDASIL 9 injection (strength, dose, route of administration, lot # and expiry date were not reported) in the HPV vaccination series for prophylaxis. On 15-JUN-2018 (reported as now, at the age of 18), the patient was at the pharmacy and was late for his second dose of GARDASIL 9 in the human papilloma virus (HPV) vaccination series. No adverse effects were reported. There was no product quality complaint (PQC) reported.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # J014854, expiration date 16-JAN-2016 or lot # L009445, expiration date 01-JUN-2017, exact doses and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
I received my first dose of Pfizer in my left arm on September 28, 2021. Roughly a few days later. I started to experience horrendous smells and tastes with the majority of foods and any item that has a smell. I received my second dose of Pfizer in my left arm on October 19, 2021. This issue has only got worse over the last several months. I am extremely limited to what I can eat, drink, and hygiene products I can use. From my own personal research, I have discovered this is Parosmia. I have reached out to individuals who are experiencing the same issue, in person and online. I would describe the smell and taste as a rotten meat and chemicals,  I am still suffering from this.  My menstrual cycle has also been impacted. I was made aware that this could change after the first month or so but it has not. I have been on birth control since March 2021 and that helped my premenstrual symptoms and regulate my period. After receiving my vaccine, my menstrual cramps were almost unboreable, large clots, earlier start and an extremely heavy flow. I was hoping this would improve for my second cycle after being vaccinated but I was wrong.  I am still experiencing these symptoms months later.   I received my vaccine at (privacy). We have a site nurse who is employed through Hospital, which is where I assume, she would retrieve the vaccines to administer to employees.
Patient vaccinated a.m. of 3/6/08 - in afternoon of that date patient complained of "hives" on arms and face, "feeling feverish", trouble breathing - temperature at follow-up exam 97.3, no visible rash or swelling, lungs clear, no symptoms.
Numbness of extremities and mouth. Inability to control limbs. Inability to stand/walk. Started 5/31 and got progressively worse leading up to admittance to hospital on 6/9. Inconclusive diagnosis from hospital so admitted to a physical therapy rehab facility on 6/16
Numbness in arm. Joint pain in arm. Tenderness of injection site. Flu like symptoms. Headache.
Approximately 24 hours after vaccine noticed an itching with a raised 2.5" red welt at injection site. Ice pack applied.
October  2018  1 flu vaccine  :  Seqires, FLUAD., 0.5 ml, 70461-001803 (NDC)        4         internist ? visit for hoarseness                   ENT,? endoscopic exam, all structures normal       During the month ?               Voice ? lower pitch, hoarse, less strength               Hand/ eye ? vision reduced, sometimes double, blurry               Gait ? less coordinated, balance off               Writing ? harder, rougher, not sequenced correctly               Eating ? swallow okay, hard to get food from plate to mouth               Mentation -  confusion regarding dates, emotional changes  Still driving and working Worsening during the month My secretary repeatedly told my husband something was wrong.   November       1,2 ? veering in car, awkward turns 2 -  planning trip for boat trip  3     Cancellled, not safe on roadways            12 ?neurologist ? first MRI    10/1/2018  vaccination date   10/4/2018  3 pm visit for hoarseness 10/18/2018 appt  unrelated to this issue 11/12/2018  MRI and an appointment with Dr 11/13/2018  Dr at hospital 11/27/2018  Admitted 11/27/2018 ? 12/07/2018 11/27/2018  ECG Dr (ER Doctor) 11/28/2019  ECG Dr 12/4/2018  MRI under anesthesia 12/7/2018 ? 12/24/2018  Rehab hospital 1/8/2019  MRI Dr outpatient 11/2019   1/2019  clinic spinal tap 1/2019 Dr 2/12/2019  clinic  MRI Dr 5/29/2019  clinic MRI 10/30/2019  Dr local Neurologist 12/12/2019  Dr integrative MD 1/24/2020  Dr follow up 2/25/2020  Dr Virus antibody 3.56 6/30/2020   - telemedicine 9/4/2020   fx R femur 8/15/2021  fx L femue 8/5/2022  vocal polyp sx
This spontaneous report as received from licensed practical nurse refers to unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On 01-JUN-2013, the patient was vaccinated with PROQUAD (dose strength and route was not reported). Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. All products had been administered. No adverse effects reported by any patients. Nurse was compiling lot and expiration date information and would call back for further evaluation. No PQC was involved. The outcome of excursion of 6F since 01-JUN-2013 and products were not stored in an overall average support range of -58 degree F and 5 degree F was unknown. No further information was provided. This case is linked to MARRS # 1412USA010657 and MARRS # 1412USA010450 via same reporter link. Additional information has been requested.
No recognizable chickenpox (wild-type) by history. Pt given routine varicella vax within the last year. Pt now presents with shingles in approximate right distribution.