chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced redness and discomfort in the arm she received her Moderna booster vaccine. Patient also reported it has improved and getting better.
This spontaneous report as received from a physician via a company representative refers to the three different patients of unknown age and gender. No information on patient's pertinent medical history, drug reactions or allergies was reported. On an unknown date in April 2016, the patients were vaccinated with a dose of M-M-R II intramuscularly (dose, lot number and expiration date were not reported). Concomitant medications were not reported. On unknown dates in 2016, the patients developed measles. The outcome of the measles was unknown. the relatedness between the measles and the M-M-R II was not reported. Upon internal review, the measles was determined to be medically significant. Additional information has been requested.
1-2 days after second Pfizer vaccine developed pulsatile tinnitus in left ear. Hear echoey wooshing sound.
Pfizer Covid Vaccines: Covid positive after 5 vaccines; Pfizer Covid Vaccines: Covid positive after 5 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), she has not been diagnosed, but she knows she has anxiety. Stated that it was not a new condition for her; "she hasn't slept well" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing), notes: 25 years ago. Concomitant medication(s) included: TRAZODONE taken for sleep disorder (ongoing). The patient stated that the 5 shots she mentioned receiving were 5 doses of the Pfizer Covid Vaccines. She got her first ones back before anyone else because the hospital her daughter works at offered them to the families of nurses.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer Covid Vaccines: Covid positive after 5 vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive; (12Dec2022) Negative. Patient mentioned that she tested positive for Covid last Tuesday (08Dec2022) and tested negative in the morning of 12Dec2022 with a home test. She called the doctor. Her husband had tested positive on Monday or Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 06Dec2022 to 10Dec2022 at 3 tablets twice a day by mouth. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372357 same patient and suspect drug, different event and dose;
Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Apr2021 at 05:15 PM (17:15), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 04Mar2021 for COVID-19 immunization (left arm). The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 02Apr2021, the patient experienced right lip swelling and paralysis. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
04/12/2018 Mild Rash within 14 days of dose. Rash/fever developed after 1st varicella vaccine given - noted rash and a few red spots on left lateral thigh by injection site from mother report. Also has had fever on/off from 99-101 degrees; improved some since 4/12/18.
Burning of the eyes, and stomach, along with nausea. BP's 142/46 (pulse 64), 155/60. Given juice and crackers.
Changes in menstrual cycle length, resulting in a false pregnancy (yoke sac present but no fetal development) and resulting miscarriage and cycle variations for the next several months.
Short dizzy spells, sometimes pretty strong. The first one (and the strongest) was on April 14, nine days after vaccination. It lasted between 30 and 60 seconds. Today, eleven days after vaccination, I'm experiencing them more often but not as strong.
2nd Pfizer Covid-19 vaccine received by patient on 2/24/2021 & patient developed a rash on his right shoulder on 2/25/2021. Rash remains present & has spread to lower chest, so patient completed a virtual visit with PCP's office today, 3/11/2021. Patient reports blisters when rash initially started; patient denies fever, chills, pain at this time. PCP notes that scabs have developed & rash has spread to lower chest. PCP states 'Do not recommend medications at this time given time of rash course & no new lesions present. Tylenol for pain. Advised that rash should resolve after a month.'
Immediately after receiving vaccine recipient stated that he felt faint. Eyes rolled back and he became limp. Two nurses laid him on floor. He came to within seconds but was diaphoretic. Vitals were checked and monitored (BP 130/70, 118/74, 120/72; pulse 57, 72, 68; pulse ox 98%, 99%, 99%). He quickly felt better (within a few minutes), was given water, chocolate and a granola bar. He stayed in observation a total of 35 minutes. He reports that he had been very nervous about getting a vaccination. He returned to his unit with a colleague. We checked in with him a few hours later and he reported that he felt well.
Developed abdominal pain, nausea, vomiting, fever and cough within 12 hours of receiving COVID 19 vaccine. Had COVID 19 in November of 2020.  Severe enough symptoms to go to the ED. Received IV fluid, and zofran. Admitted to observation status and received IV pain medication for headache, enema, due to obstipation.
This spontaneous report was received from a registered nurse referred to a 4 year old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Therapy Type: rHA) (strength, dose, frequency and route of administration were not reported) (lot # N020620, expiration date: 22-JAN-2019) for prophylaxis (product storage error). The vaccine was stored in between -14 degrees Celsius (C) to -10 degree C (-10 degree C) for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This case is linked to the case 1803USA007736 (same reporter link).; Sender's Comments: US-009507513-1803USA007736:
4pm pt. was given GARDASIL and BOOSTRIX I.M. pt was pre syncope, cold compress applied to forehead. Pt was moved c/o exam room - place on table and lay down. BP 80/50, P 80, 414P BP-90/60, P-580, 420P BP 92/60, P- 80, 425P -pt states she feels better, 430P BP 92/62.
Developed itching hives on ankles and legs.  Slight itching arms and shoulders.  Presenting as small red bumps and at times raised skin colored areas. Treating with Benadryl and hydrocortisone cream.  Have contacted doctors office to see if there is anything else for treatment.  Symptoms started 10 days after receiving J&J covid vaccination and at this time have lasted for 4 days.
Telephone call today from mother 1/17/03 to report - patient c/o heaviness in her chest at 2 a.m. on 8/8/02 - "Like an elephant was sitting on her chest" also had tingly feeling from her neck down to chest. No other concerns. Did not call site - no other prob's since that time.
6 hrs after shot started feeling fatigue and chills. 12 hrs  after shot started body aches.  Fatigue and body aches lasted 36 hrs. Night sweats next 2 nights.
Varicella vaccination was given IM instead of subcutaneous (in the (L) thigh). No reaction observed.
being treated for chronic cough that was getting worse despite nebulizer treatments, went to er and tested positive for covid 19 on  3.30.23; hospitialized 3.30-4.1.23.  Probable exposure at a pizza place on 3.25.23
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      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.
Rash, itchiness at vaccine site that spread across trunk and up to face. Patient then had rash, swelling, tightness of face and lips
PT is reporting involuntary trembling and shaking of her arms and/or legs that lasts for a short period.  She is reporting that this has happened about four times since getting the shot, with the first time occurring in the middle of the night the day after getting the shot.  Last instance was tonight around 8pm.
Body aches; flu like symptoms; fatigue; slight fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number : FD8448 and expiry date was not reported) via an unspecified route of administration, in the right arm, at the age of 69-year-old, on 08Oct2021 16:00, as  dose 3 (booster), single for covid-19 immunisation in a pharmacy or drug store. The patient medical history included hypertension and hyperlipidemia. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not tested for Covid-19. The patient's concomitant medications include influenza vaccine inact sag 4v (FLUAD QUADRIVALENT) on 29Sep2021 for immunization, atenolol, enalapril, and atorvastatin.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EM9810 and expiry dates was not reported) on 04Feb2021 13:00, as dose 1, single and (lot number: EN6203 and expiry dates was not reported) on 27Feb2021 14:00, as dose 2, single; both given via an unspecified route of administration, in the left arm, at the age of 69-year-old, for covid-19 immunisation. On 09Oct2021 08:00, the patient experienced Body aches, flu like symptoms, fatigue, and slight fever for 2 days. The patient didn't receive any treatment in response to the event. The outcome of the event fever was recovered on 11Oct2021 while the other events recovered in Oct2021. The events were assessed by the consumer as non-serious.  Follow-up attempts are completed. No further information is expected.
some of the vaccine sprayed out in to the HCP eyes; some of the vaccine sprayed out while giving 1st dose using Vanish point needle; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes), UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes), UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle). On 15-Mar-2021, EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes) outcome was unknown and UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) 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.   This report refers to a case of vaccine underdose, syringe connection issue and exposure via eye contact for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure via eye contact for mRNA-1273, lot # unknown with no associated AEs.
Within 24 hours after receiving vaccine, patient developed fever 100. 4, body aches, chest tightness and shortness of breath with exertion
Pfizer given as first dose (Lot = EL0142 on 1/15/2021) Moderna given as second dose (Lot 016M20A on 2/5/2021) No adverse reactions notes, patient & Health Department Medical Director notified Reviewed dosing schedules & recommendations w/vaccine administrator, reviewed signage @ clinic delineating separate areas for Pfizer & Moderna vaccines
Pt reports around day 1 or 2 after receiving 1st dose of Moderna, the injection site became irritated and began itching. Pt states on day 6 her symptoms resulted into cellulitis.  Pt stated she called her PCP and informed him of symptoms. Pt stated she is a doctor and she did not go in to be seen by her PCP. Pt reports to taking Zertec and Benadryl and noticed relief of symptoms after 48 hours of taking medication.
1 fo 2 pts vaxed from the same vial devel inject site react; pt exp swelling of entire deltoid msucels, blotches, induration @ the site (2" square) & tenderness to touch; MD visit; steroids given; sx improved w/in 24 hrs; no cultures taken;
It had burst and bled in my abdomen; I had a good sized ovarian cyst in my right ovary rupture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: Er8735) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Possible iodine allergy" (unspecified if ongoing), notes: Verbatim: Possible iodine allergy; "Seasonal allergies" (unspecified if ongoing), notes: Verbatim: Seasonal allergies; "Chronic pain" (unspecified if ongoing); "PVC's" (unspecified if ongoing), notes: Verbatim: PVC's; "PTSD" (unspecified if ongoing), notes: Verbatim: PTSD. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine", notes: Verbatim: Known allergy: Reaction to numbing medicine with epinephrine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: INTERNAL HAEMORRHAGE (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "It had burst and bled in my abdomen"; OVARIAN CYST (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "I had a good sized ovarian cyst in my right ovary rupture". The events "it had burst and bled in my abdomen" and "i had a good sized ovarian cyst in my right ovary rupture" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ultrasound scan vagina: (20May2021) it had burst and bled in my abdomen. Therapeutic measures were taken as a result of internal haemorrhage, ovarian cyst.  Additional information: patient reported that A Day after her second covid 19 shot, she had a good sized ovarian cyst in my right ovary rupture that she had no idea she has. She had to go to the ER and get an ultrasound transvaginal. It had burst and bled in her abdomen. She was fine now but have another cyst and just got her 3rd Pfizer covid-19 vaccine. No covid prior vaccination. No covid tested post vaccination.Therapeutic measured included check ups and  observations with pain meds and rest.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a local site reaction. No further information is available. Additional information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a red itchy area and swelling.
Itching, red and swollen left tricep, caused by 3rd Anthrax shot. 28cm X 24cm erythematous, warm and indurated left upper arm extending past elbow into forearm, FROM, plus a deep ache.
No additional AE details or PQC.; an expired GARDASIL 9 administered to a patient; This spontaneous report was received from a medical student, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 14-MAR-2022, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S022599, expiration date on 25-FEB-2022, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). No other adverse events were reported (no adverse event). Additionally, it was reported that no temperature excursion.
Injection site soreness; Difficulty lifting arm; Arm heaviness; Muscle aches; Influenza-like symptoms; only the adjuvant was administered without the antigen; only the adjuvant was administered without the antigen; feeling tired; Sniffles; Gastrointestinal symptoms; Altered digestion; Increased urination; This case was reported by a consumer  and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain, mobility decreased, tiredness, sniffles, gastrointestinal symptom nos, urinary frequency, muscle pain and influenza-like symptoms were recovered/resolved and the outcome of the heaviness in arm, digestion impaired, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the pneumonia vaccine one month earlier to Shingrix. It was reported that patient received the Shingrix with only adjuvant part and experienced symptoms including injection site soreness, difficulty lifting arm due to heaviness, muscle ache and flu-like symptoms. 24 Hours after the vaccination patient felt tired with mild sniffles, gastrointestinal symptoms including altered digestion, and increased urination. As patient received the Shingrix without antigen,which led to iappropriate preparation of medication and inappropriate dose of vaccine administered. It was reported that the symptoms lasted approximately 1-2 days. The blood test was performed for antibody levels which demonstrated antibodies to shingles. Patient was unwilling to be re-vaccinated with properly reconstituted Shingrix vaccine due to having side effects from adjuvant.
felt lightheaded, woozy-color bright pink-face & extremities;HR elevated 110, BP 190's (was 136/70 a/vax); mouth felt dry-tongue swollen sl;
Tingly around injection site; Redness around injection site; Tenderness around injection site; Itchiness around injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly around injection site), MYALGIA (Sore arm), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Sore arm). On 15-Mar-2021, the patient experienced PARAESTHESIA (Tingly around injection site), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site). At the time of the report, PARAESTHESIA (Tingly around injection site), MYALGIA (Sore arm), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment medication: cortisone cream, anti histamines.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: patient contact information was updated
Tossed & turned all night...woke up 7am w/ chills & weakness & sore arm. Feel feverish. Temp is 99.9. No energy & a little nauseous. Body aches.