chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Pt rec'd vaccine late a.m. In middle of night it became painful to lay on (L) side. The next a.m. there was a hard painful lump where imm. was administered. It was also hard and hot. No fever/chills. Erythema induration and warmth 11x17 cm three days later. Cephalexin 500mg QID rx'd #28. Pt afebrile at time of appt 3 days later.
Initial report received from a health care provider on 3/21/06. A five year old male pt, with a history of an allergy to tree pollen, had received, on 3/14/06, a fifth dose , left arm injection of Tripedia, lot number U1635CA, a fourth dose left arm injection of IPOL, lot number Y0638, and a second dose , left arm injection of MMR vaccine, lot number 0466R. Within 24 hours post vaccination, the pt had developed a softball sized area of redness, swelling, warmth and soreness. At the time of this report, the pt had not recovered from the event. Follow up information received on 4/10/06. The pts event did not require a doctors visit. Routes of administration of the vaccinations were provided. At the time of this report, the pt had recovered.
all the arm hurt and was very sore; injection site pain; body ache; their body was painful like getting the flu.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer in remission (Patient was going through cancer remission and their immune system is very low.).    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.). At the time of the report, PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided
Fever began 12 hours after shot. Was 101.6 for 12-15 hours. Aches, pains, headache
Patient with grandmother to receive vaccines. After administration of vaccines at 9:55am, patient stated having a headache. Nurse noted pale and clammy skin, and vitals were taken at9:56am with BP100/66 , HR 62, 0xygen saturation at 100 %. Patient then stated feeling thirsty  at 9:57am, water was provided and AAOx4.  Vital signs were taken at 10:03am,  BP 106/84, HR 80, oxygen saturation at 100%. Patent was able to continue communicating and verifying name and date of birth . Patient stated , " im starting to feel better now". VS taken at 10:08am with HR at 77, Oxygen saturation at 100 %, BP 104/80 with signs and symptoms of improvement. At 10:15 patient reported not feeling lightheaded, headache had diminished,  and showed no signs of distress. Patient and mother were advised if symptoms were to return , to seek emergency assistance. Both patient and mother verbalized understanding. Patient was able to stand up slowly without assistance and was released from our care.
Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted.  She hit the tile floor.
Noticed numbness in left thigh on 24 DEC 2020 approx 1200 pm. Not accompanied by any tingling, noticeable weakness, other pain, redness or swelling. Numbness has persisted through the present date.
Within about 4 months of receiving the Pfizer COVID vaccine, the patient developed worsening lower extremity edema. This was first noted on 9/21/21 during a routine office visit, though her family reported that the edema had been progressing over the previous weeks/months. On 10/12/21, the patient was hospitalized for a UTI and diverticulitis, but developed acute diastolic dysfunction on or around 10/18/21, which prompted an Echoy, which showed moderate-severe pulmonary hypertension. She was discharged from the hospital on 10/22/21, only to be readmitted on 10/24/21 for acute hypoxic respiratory failure secondary to fluid overload.
Patient called 10/4/21 in the morning about 9:20am stating he had adverse reaction to Varivax shot (indicated the shot in the back of the Right arm) that he had received 9/20/21--stated that he had itchiness, swelling, and red spots start to develop just yesterday 10/3/21 and that it had spread to more spots across his body in at least 3 different locations. Described them as itchy red blisters/bumps. Also said that he has cold/cough symptoms, body aches, and has experienced shivering at night. I called and talked to Merck who sent me clinical trials stating that it is an adverse reaction, indeed.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown demographics who received Hib component with sterile water for injection of suspect vaccine PENTACEL (lot number: C5573AA and expiry date: 13-Oct-2019) (dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to wrong solution used in drug reconstitution. It was reported that the patient was given the ActHib portion with sterile water for injection and not the DTaP IPV portion. It was not reported if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender- none.
Around August 17th I felt very tired and had a bad stomachache that lasted about two days. Also, I experienced sores all over my mouth and tongue, and blister all over my hands and feet. Going up my right leg I had small blood red spots that was accompanied by a burning sensation that comes and goes. I had absolutely no energy throughout the day. By Friday I was a lot better and on Saturday I felt completely better. I still have red spots that are slowly but surely disappearing. There were no medical test done besides the normal check in for going to the doctor's office.  They stated that it was just a virus that I had caught with not much information about what was going on.
Sweaty, nausea, clammy, she does have a fear of needles.
This spontaneous report as received from a nurse via company representative refers to a male patient of unknown age (the reporting nurse's husband). The patient's pertinent medical history was not provided. On an unspecified date in approximately 2013 (reported as last year), the patient was vaccinated with ZOSTAVAX (route of administration, lot number and expiration date were not reported). No concomitant medication was provided. On an unknown date, the patient experienced chicken pox. The reporter stated that the pox was on the patient's head and "in his beard". The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
High Fever, hives, swollen arm- 5 times the size of regular arm, pain, bright red swelling, burning. Needed and treated with Antibiotics due to autoimmune disorder and severe allergic adverse reaction to vaccine.
Persistent nausea without clear etiology, started on 4/23 and persistent until 4/30
Vaccinated pt (self report) admitted with symptomatic covid infection. No info available on type, place, lot, date, etc. of vaccine
The normal site pain from the needle stab, and several minutes later a sympathetic pain in the right shoulder.  Sounds crazy, but the same thing happened to my sister and one of her friends.  Sometime later after arriving home, I developed chills.  At 10:30 pm I took two extra strength acetaminophen capsules (500 mg, ea.).  That eliminated both the chill and the right shoulder pain by 11:30.  Today, the 18th, I am feeling fine except for the injection site pain.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     it was unknown if patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medications were reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that the expired Moderna COVID-19 monovalent vaccine was administered to patient on 15-MAR-2023. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Approx 3 hrs p/receiving vax pt began w/a high pitched scream; pt screamed inconsolably for 3-4 hrs;
FYI based on handwriting I can't tell if the lot # is E11686, EI1686, or EL1686.  A few days after the first dose I felt chronic mild chest pain which I had never felt before, then I noticed on my watch that my RHR average, which was around 62-64, jumped to 72-74. My RHR stayed elevated through the second dose (lot: EL9261). Same mild chronic chest pain. At one point in the middle of the night I had IMMENSE chest pain that it woke me up but my heart rate was normal. I almost called an ambulance. The mild chest pain and my RHR finally went down about 3 weeks after the second dose, although now my RHR is consistently at 65-67. I am terrified each one of these doses is permanently damaging my heart. I forgot about it until the articles about myocarditis came out in May. My new doctor didn't seem to care because I brought it up so after the fact. Didn't know I could file a report myself.
At 3:15 p.m. patient's mother reported to nurse patient was feeling nauseas. Nurse assessed patient, VS obtained B/P 87/39 P 57 RR 18 O2 SATS 99%RA. RRT called. Patient given 8oz of water, patient drank. Patient remained alert and verbal. Patient placed on stretcher.  At 3 :17 p.m. VS retaken B/P 99/64 P 68 RR 18 O2 SATS 100%. RRT arrived at 3:18 p.m.. Patient taken to ER at 3:19 p.m. for evaluation. Patient remained alert and verbal, stated she was feeling better. Mother accompanied patient to ER.
Shingles lower back rashFacial filler edema; Shingles lower back rashFacial filler edema; Shingles lower back rashFacial filler edema; dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EW0162); This is a spontaneous report from a contactable consumer. A 41-years old non-pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 (at the age of 41 year old )as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EW0162) as dose 2, single for covid-19 immunisation. Medical history included eczema, psoriasis. There were no concomitant medications. Prior to 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. The patient experienced shingles lower back rash facial filler edema on 21Apr2021 14:00. The outcome of events was recovered with sequelae.  Follow-up (12Jul2021): Follow-up attempts are completed. No further information is expected  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected
Swelling from right eye to below cheekbone to chin.  Slight redness and itching.  Took Benadryl
Pt received varicella virus vaccine live on 11/5/98 and on 3/22/99, post vax, the pt experienced a case of breakthrough varicella. It was reported that the pts brother had chickenpox.
Jitters and increased anxiety and feeling of being overwhelmed.  Prescribed Prozac 10 mg daily at this office visit.
3x4 inch red warm tender area around site of injection.  Resolved in 5 days.
pt recv vax 31AUG95 & 21MAR96 pt exp many lesions involving face, scalp, behind ears, & chest & titer was less than 1 to 8;no fever was recorded but pt felt warm to the touch;pt recovered from many lesions involving face, scalp, behind ears
DIZZINES AND SYNCOPE AFTER APPROX 10 MIN OD ADMINISTERING FLU SHOT. NO LOSS OF CONSCIOUSNESS. HELP HIM TO RECOVER, WHICH HAPPEN AFTER ABOUT 15 MIN.
Came down with COVID; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Came down with COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with COVID). At the time of the report, COVID-19 (Came down with COVID) had resolved. Not Provided      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.
doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) in a 60-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Patient mentioned today, 10/1/21, he was still experiencing bilateral arm and shoulder pain that occurred after his 3/16/19 injections.  He mentioned to doctor but no follow ups have been conducted or additional medical treatment, though he explains he has had reduced mobility and quality of life as a result.
2.5 x 5cm induration and erythema with red dot (injection site) in center of left shoulder; also ill defined day pink skin skin of cheek and chin. Began 1 day after shot, no fever, redness gone, still has lump under skin where given injection 7 days ago.
RIGHT AND LEFT THIGH AND CALF PAIN, THE DISCOMFORT SUBSIDES AFTER MOVING AND WALKING A BIT, PAIN WAS TOWARDS THE FRONT AND WORSE ON THE LEFT; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient has no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 06-OCT-2021, the patient experienced right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. This report was non-serious.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding 5 year old female patient (child). On 29-JUL-2014 at 1:32 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number K007158, expiration date 12-NOV-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified, The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
pt reports noc sweats 2-3x/wk beginning 3 days or more p/vax;also some myalgia but no arthralgia w/sweats;temp not noted;blanching macules 2-3mm in diameter;afeb;rt conjunctivitis;serum sickness;
This spontaneous report was received from a physician referring to a 14-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 17-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
pt said 5 hours after the vaccine she felt dizzy and site of injection was swollen, red and painful.  Pt went to the emergency room and was given antibiotic for possible cellulitis.  Pt also had a very complex problem going on with bleeding and needed a blood transfusion at the time for a bleeding problem she had post procedure from 12/11/2022
Date and time adverse event started: 04/12/21 around 1630 pt started feeling chills, sore throat, cough, congestion and fever.Stayed in bed, did not go to HCF/ED/PCP
Pt recvd 3 doses of Hep B vax & recently, pt was tested & found to have post anti-HBs & anti-HBc titers; pt was asymptomatic & liver function tests were nl;
4day p/vax pt woke vomiting followed by 10-15 min of paleness of color, limpness & staring. taken to ER, fever 101. DX c (om) treated w/amoxil, 7/18, again episode vomiting, paleness, 30min limpness, paleness & staring. in ER blood work don
This spontaneous report as received from a nurse refers to a 4 month old patient. On an unknown date the patient was vaccinated with ROTATEQ (lot # not reported) dose 1, oral, at the age of 4 months due to a data error that resulted in the administration of ROTATEQ outside of the prescribing information for the recommended age. No adverse effect was reported. Additional information is not expected.
Starting at 11:00 pm 8/10 started with nausea, injection site swollen, hot and red.  By 8/11 at 1:00 am started to get the chills, fatigue, increased nausea, body aches, abdominal pain continued until 7am.  Nausea and chills contiued throughout the day with abdominal pain and a severe headache.  8/12 Nausea continued with abdominal pain, fatigue, and body aches.