chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Major case of shingles after the vaccine/suspected vaccination failure; Shingles in ears; Shingles on face/scalp; Stressed; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (almost 18 years before date of reporting patient brother have very mild case of shingles broke out in his armpit) and post herpetic neuralgia (patient brother still have nerve pain in his feet and back).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Major case of shingles after the vaccine/suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles in ears) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on face/scalp) and stress (Verbatim: Stressed). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, shingles and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that he nagged his sister to receive the Shingles vaccine. The patient after received Shingles vaccine experienced broke out with major case of shingles on her face, scalp and in her ears. The reporter stated that it was horrendous and anytime the patient got stressed she broke out with the shingles again. The reporter stated that he was not getting the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from a Pfizer-sponsored Program Pfizer First Connect. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscularly on left deltoid on 21Dec2020 (between 2:15PM and 2:30PM) at single dose (reported as 225mcg/.45ml intramuscular suspension) for COVID-19 immunization. The relevant medical history included birth control. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) for birth control. The patient received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19. She wanted to know if the vaccine could have caused a positive test result, if the test assesses IgM or IgG (to the viral spike proteins), could a false positive result be caused by the vaccine. She hadn't been able to get up with her primary care on the phone. This was her first dose. The window to get the second vaccine is 07Jan2021 through 11Jan2021. The patient did not require a visit to emergency room or physician office. The outcome of the events was unknown.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Menstrual cycle has been going on for many days,is longer than normal; has irregular start dates for her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 021B21A-1) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle). At the time of the report, OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.
Patient with known prior Covid infection.  Felt fine after first injection.  Within two weeks of second injection, developed recurring hives.  Was seen in the ER and treated with prednisone, H1 and H2 blockers.   Has not been able to go off prednisone.  Noticed recurrence of the fatigue she had at the time of her original illness as well, shortly after the second vaccine.
mild h/a 29MAR93 h/a worse w/some vomiting 30MAR94; awoke 31MAR93 w/h/a p/taking Typhoid; 1APR4 w/some nausea & fever; seen in ER adm to hosp w/nausea & dehydration;
Initial report was received on 03 October 2013 from a non-health care professional. A patient (gender and date of birth not reported) had received on 03 October 2013 an intramuscular injection of FLUZONE (Sanofi Pasteur lot number and site not reported) and "immediately" on 03 October 2013 had oral swelling. No further information was provided at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Initial report was received from a consumer, who was also the patient's parent, on 09 April 2012. A two-month-old patient had received an injection of IMOVAX Rabies, sanofi pasteur SA (lot number, route and site unknown) on 31 March 2012, 03 April 2012 and 07 April 2012 and an injection of Immunoglobulin human antirabies (manufacturer, lot number, route and site unknown) on 31 March 2012. After the third dose of IMOVAX on 07 April 2012, the patient "went limp and was like a rag doll for 10 minutes." The patient also had "scaly dry areas at every injection site for IMOVAX and Immunoglobulin." The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported. The patient's outcome was not reported. Documents held by sender: None.
Prepared vaccine syringe was accidentally placed in a cooler with -80 ice blocks. The mistake was recognized within 2-5 minutes and the syringe was removed from the cooler. Ice crystals were observed in the vaccine product in the syringe. The ice crystals dissipated immediately and the vaccine returned to liquid. We did not initially consider this to be a deviation from normal vaccine storage. The patient did not exhibit any adverse events to the vaccination.
Pt received first Moderna COVID shot 2/25/2021. Pt developed acute on chronic respiratory failure with hypoxia, presented to local hospital ED on 3/25 and transferred to our facility for higher level of care.  Currently in ICU with covid related hypoxia and pneumonia.
Approximately 5 hours after adminsttration of flu vaccine. Pt complained of itching and swelling of hands, feet, feeling flushed and nauseated. Had 2 large welps on upper back. Took 50 Benadryl by mouth and had improvement of symptoms.
Day 1 (9/22/22): allergic reaction at injection site. Hot to touch, golf ball size knot, red blotch about the size of a baseball.  Day  4 (9/25/22): hives stemming from injection site across collarbone, neck, and throat. Took Benadryl and used Benadryl cream for a week. Hives began to subside on Day 9 (9/30/22), but itching continued.  Day 11 (10/2/22): back began to itch and wouldn't stop.  Day 12: (10/3/22): entire body began itching and breaking out/swelling, including lips and ears. Went to Urgent care and received a steroid shot and a 5 day prescription of Prednisone and a prescription for medicated itch cream to use. Instructed to take cold showers as often as needed and to use calamine in between using the medicated cream twice daily.  Day 13: (10/4/22): face, lips, and ears started to itch less, but back, trunk, arms, and legs itched more.  Day 16 (10/7/22): rash on body except back began to subside but still itched on whole body except face.  Day 19 (10/10/22): itching finally stopped.  Day 24 (10/15/22): Black ink on 7 month old tattoo began itching and being raised. Proceeded to get worse daily.  Day 28 (10/19/22): black ink on a second tattoo that is 5 months old began itching and being raised. Going to doctor tomorrow. Put in call to allergist.
WRONG VACCINE ADMINISTERED TO PATIENT BY NURSE, NO ADVERSE REACTION NOTED.
Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, and low grade fever (100.6F oral temp). Symptoms largely resolved within 24 hours; however, had persistent eye soreness (pain with lateral movement) through 72 hours post-vaccination for which additional evaluation was sought.
This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient had fatigue, nausea, headache, pain/general soreness and influenza-like illness (flu-like symptoms), onset Apr 2021, with outcome of recovering. No therapeutic measures taken as a result of fatigue, nausea, headache, pain and influenza-like illness. Additional information: Reportedly, patient had fatigue, nausea, headache and general soreness. Patient also had moderate flu-like symptoms (described as feeling awful) until 24 hours after the second dose. She is presently recovering. These symptoms did not require any treatment or attention by an HCP. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
"Administered - 13:30 Adverse event started - 13:40 Patient had light headedness, palpitations, cold hands. BP 155/97 -- > 159/90 -- > 149/89 (changed to high Fowler's position) -- > 120/69 (standing position), HR 85 -- > 87 -- > 69 -- > 81, RR 18, O2 100%, A&O x3.  checked patient. At 13:38 same day, patient denied symptoms."
reports left shoulder pain following his second COVID vaccine. Dates of vaccines: 3/30/21 and 4/20/21. Started after the 4/20/21 one (3 months ago).  It hurt for a couple days and never went away. Can not rotate shoulder, and lift arm up without lots of pain. Hurts to push on the area.  Shows location of injection is over deltoid muscle.  Treatments tried: Ibuprofen. The prescription meloxicam 7.5mg and it helps him. Cannot sleep on shoulder if he does not take the medication. Meloxicam helps decrease the pain.  Denies: fevers, chills, numbness, tingling, loss of strength.
pt devel rxn to vax;@ inj site 10 days later devel indurated, warm & painful arm & 2-3 vesicles devel @ inj site few days later;satellite vesicles appeared profound to inj site on upper shoulder;
Started on the day with flu like symptoms with severe body pain. Lasted 3 days used tylenol.
Itchy arm post booster shot of Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Manufacturer unknown), for Covid-19 Immunization; Bnt162b2 (Second Dose, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchy arm post booster shot of Covid"  Additional information: Event took place after use of product. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Ankles and legs a bit swollen; Bruising around ankles; Achy; Ankles and legs a bit swollen; ache as much, just in his shoulders; This is a spontaneous report from a contactable consumer (patient).  A 32-years-old male patient received BNT162B2 (BNT162B2, Solution for injection, Lot number: EW0179), via an unspecified route of administration, administered in arm left on 11May2021 (vaccination time was reported as 11:00 or 11:20) as DOSE 2, 0.3 ML SINGLE (at the age of 32-year-old) for covid-19 immunisation. The patient's weighs was 270 or 260. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in arm left on 20Apr2021as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient took no medications and had no medical conditions. The patient had no prior vaccinations within 4 weeks. On 12May2021 (also reported as maybe around 08:00), the patient woke up this morning with ankles and legs a bit swollen, bruising around ankles and achy. The achiness was better in his knees. He noticed the swelling just a little bit ago before he made this call. He does not ache as much, just in his shoulders. The patient asked if that was related to the vaccine or if he is paranoid. Patient did not visited to emergency room or physician office. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Developed paresthesias (numbness and tingling). Initially in the right arm x 1 day on 4/1. Subsequently developed more persistent parestheias in the right lower extremity on 4/14. Had similar lower extremity paresthesias in the past, but these were brief and never persisted. Over the next week developed paresthesias in the left arm and leg, aslo the neck and lower face.
Left lower extremity swelling from the knee to the thigh, warm to touch, temperaure to 102, upset stomach
Spicy tingling sensation at the tip of the tongue to taste; Spicy tingling sensation at the tip of the tongue to taste; Fever; Cough; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 at 17:00 (Lot number: PH8030) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing), notes: As a child. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FJ1611; Anatomical location: left arm; Administration time: 17:00; Route of administration: unspecified), administration date: 01Dec2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: PARAESTHESIA ORAL (non-serious), GLOSSODYNIA (non-serious) all with onset 24Dec2021 at 16:00, outcome "recovering", and all described as "Spicy tingling sensation at the tip of the tongue to taste"; PYREXIA (non-serious) with onset 24Dec2021 at 16:00, outcome "recovering", described as "Fever"; COUGH (non-serious) with onset 24Dec2021 at 16:00, outcome "recovering", described as "Cough". Therapeutic measures were taken as a result of paraesthesia oral, glossodynia, pyrexia and cough. Additional information: The patient had no allergies that he knows of. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included lots of green tea and NyQuil for PARAESTHESIA ORAL, GLOSSODYNIA, PYREXIA and COUGH. Since the vaccination, the patient had not been tested for COVID-19.
Severe headache beginning around 9:00 PM after vaccination.  Extreme fatigue for approximately 48 hours.  Some fever and chills.  Lack of appetite.
Fever, chills, muscle pain, no appetite, neck stiffness, cough, nasal congestion, pharyngitis, conjunctivitis.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. Patients' medical history and current conditions were not reported. On an unknown date, the patients received second dose of vaccinated with GARDASIL 9, one month after receiving the first dose of GARDASIL 9. No adverse effects were reported. No product quality complaint was reported. The outcome of the inappropriate schedule of drug administration was unknown. Additional information has been requested.
Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes on June 12, face tingling on June 15. Initial Diagnosis - Stye on June 13 Later Diagnosis - Shingles on June 16 Initial Treatment - Prednisone and Clindamycin Later Treatment - Valacyclovir
Severe headache, generalized joint pain, severe dizziness....; ADVIL, bedrest for 48hrs...; Better now, still slightly dizzy.
pt recv vax OCT98 & several days p/vax pt began to exp very painful arthralgia of the elbows, then ankles, wrist & back as well as welts on legs;pt sought unspecified medical attention;
Doctor ordered wrong vaccine. HPV was ordered instead of HIB. HPV was given to patient. Patient tolerated injection well. No reaction noted after 15 minutes.
It has been 6 weeks and my arm is still painful. He did not place the shot in the deltoid muscle but rather in the front part of my left upper arm. The pain severely limits my range of motion and what I can do with my left arm. My Doctor is aware.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On June 2012, the patient was vaccinated subcutaneously (SQ) with, 0.65 ml ZOSTAVAX. The nurse called to report that her husband was administered in the fatty area in the back of his upper arm at a pharmacy about 2 months ago. No adverse effect reported. The outcome of the event was unknown. The event was not related to ZOSTAVAX. Additional information is not expected.
High temperature for 4 days of 104.5, 02/10/05 through 02/13/05. Also vomited twice, loss of appetite did not eat for 3 days, decreased activity and sometimes lethargic.
No additional adverse effects reported; one patient received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's relevant history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 04-APR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # R020654, expiration date 18-JUL-2020 (upon internal validation established as valid lot # and valid expiration date) (route of administration and anatomical location were not reported), for prophylaxis. The temperature and the time frame of the excursion were not reported. It was not reported if the call was because of a "data logger". The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No additional adverse effects were reported.
Fever developing at 4 hrs; seizure 6/10 with fever; rash developed day 5 and fever resolves on day 3. ER visit/office visit.
Patient reported developing a fever and feeling fatigue approximately two weeks following vaccine administration. These symptoms she reports continue until today, approximately 39 days from when the vaccine was administered. She followed up with her doctor and reported to us that follow up tests found her to have Low Platelets and Low WBC counts, that are continue to be low.
16 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event inappropriate age at vaccine administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the 16-year-old patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.    Laboratory details was not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, inappropriate age at vaccine administration, was considered recovered/resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
got sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  Additional Information: On 31Aug2022, it was reported that patient started treatment on an unspecified date with Pfizer COVID-19 Vaccine at an unspecified dose and frequency for an unspecified indication. It was reported the patient got sick after taking the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red rash on upper arm, approximately 6 inches across below injection site. Rash slightly warm to the touch, not painful or irritating. Also soreness of deltoid muscle at injection site persisting for a few days.
MOTHER FEELS CHILD HAD A REACTION.  CHILD DEVELOPED HIVES, FEVER, PALENESS, AND "CHEST BEATING FAST" AFTER RECEIVING VACCINATION.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
My first and second shot cause my arm and armpit to swell.  Although it has gone down. It still rubs against my arm.   After the booster, I notice it happening again. This time the swelling happened more quickly and straight to armpit.
Around 8/7/22 I had slightly elevated temperature of around 99.5; overall weakness and fatigue; slight cough;  Covid home test was positive; event lasted 2-3  days; Dr prescribed Molnupiravir course over 5 days; felt better after 3-4 days
covid vaccine breakthrough case  All Moderna dose 1 3/17/21  007B21A dose 2 4/14/21  043B21A dose 3 11/26/21 067F (lot number incorrect, but do not have access to correct number)
Wheezing, shortness of breath, retractions, difficulty sleeping, fast heart rate, blue lips.