chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 1st dose of Hep B vax 03NOV89 & 17NOV89 exp aching of wrists & fingers.04DEC89 recvd 2nd vax & exp dizziness,tiredness & breathlessness. Later pt exp pain in fingers & MD dx temp polyarthritis due to Hep B vax.
Left ear pulsatile tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 20Mar2021 at 16:30 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for unknown indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021, the patient experienced left ear pulsatile tinnitus. Therapeutic measures were taken as a result of pulsatile tinnitus and included treatment with steroid therapy - prednisone. This adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event left ear pulsatile tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received 1ml instead of 0.5ml on first dose; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) 1ml on first dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection.   On an unspecified date, for the first dose, the patient received 1mL of vaccine instead of 0.5mL in one of their clinics and the patient had already received their second dose as well. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received 1mL on first dose was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unspecified age and gender who received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection and received 1mL of vaccine instead of 0.5mL in one of their clinics. There were no reported adverse events after the vaccine was administered in this case of incomplete dose.
Pt stated "Funny Feeling in her tongue"  Pt states feeling warm and nauseated.  Pt states she has a "metallic taste in her mouth"  BP 132/76  Pulse ox 97%  resp rate 20  HR 106
Dizziness  lasted an hour.  Lethargic,  chills, fever, rash on right shoulder of injection, swollen arm and fatigue for almost two weeks.
DEMAND ISCHEMIA 3/6/2022 SYNCOPE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2022 SYNCOPE  DEMAND ISCHEMIA 3/6/2022 ADVANCE DIRECTIVE ON FILE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2022 ADVANCE DIRECTIVE ON FILE  DEMAND ISCHEMIA 3/6/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE  DEMAND ISCHEMIA 3/6/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
1min post vaccination pt experienced sweating and a syncopal episode. Vitals: 88/53, 63, 20, 100% SpO2 -- > 104/67, 86 Pt stable and released from the vaccination site.
Headache, chills, nausea, dizziness, confusion, exhaustion for 2 days, then dizziness, confusion and exhaustion for 3+ additional days.  I am on the 4 day after the vaccine and completely exhausted, dizzy, and foggy headed still.
Dry cough; Throat irritation/throat felt raw; last month and a half I have gotten hoarse; Felt the heeby jeeby; Felt the heeby jeeby; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse), the second episode of NERVOUSNESS (Felt the heeby jeeby) and the first episode of NERVOUSNESS (Felt the heeby jeeby) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 03K20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Barrett's esophagus (Patient had irritation in her hroat) and Hypertension (on medication). Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METFORMIN, COLECALCIFEROL (VITAMIN D3), PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (Felt the heeby jeeby). On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of NERVOUSNESS (Felt the heeby jeeby). On an unknown date, the patient experienced COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw) and DYSPHONIA (last month and a half I have gotten hoarse). At the time of the report, COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse) and the last episode of NERVOUSNESS (Felt the heeby jeeby) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant also included OTC vitamins.  Treatment medication was not provided by the reporter.  Patient doesn't recall being sick with COVID or being infected previously.  She stated that she had a history of GERD and Barrett's Esophagus, so she always had irritation in her throat. However, a month ago she started having dry cough which she said was new and her throat felt very irritated and raw. She also stated that her voice became hoarse in the last month. She said that she did not really have any side effects from both doses except that she felt the heeby jeeby.
Mom found child apparently seizuring in crib after which continued after arriving in ED; IV started. Valium 2mg rectal in ambulance, IV 2mg in ED. Seizure 60 minute duration. Decreased respiratory rate, intubated and ventilated appropriate to blood gases, CAP gases. Air transferred to another hospital for further care.
Hives, lips and throat swelling occurred about 30 minutes after vaccination. Over-the-counter antihistamines alleviated the symptoms temporarily but in 6 hours I had to go to the ER where prednisone was administered with good effect. Feel better the next day, with daily prednisone and over-the-counter Claritin, Pepcid and Benadryl.
COVID; COVID; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing); "General Anxiety Disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone"; Hydrocodone, reaction(s): "known allergies: Hydrocodone". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06May2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2023, outcome "recovered" (02Sep2023) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2023) Positive; (02Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Aug2023 to 01Sep2023.  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-202300294586 same patient, different drug;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose number unknown (booster), single (Lot number: GH9703) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 1" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 05May2021, stop date: 28Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Jan2023 to 02Feb2023.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  drug ineffective , COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Patient reports severe pain in top right shoulder. Patient believes vaccine was administered too high up in the arm.
7/1/2023 - 7/3/2023 (2 days) presented to the emergency room complaining of nausea and vomiting for the last 2 days after being tested positive for COVID-19 treated with supportive care  038K20A 2/3/2021 031M20A 3/3/2021 045J21A 12/7/2021
Patient called pharmacy today stating that the arm that she received the Tdap vaccine in was very sore the day after receiving vaccine stating that she was even having trouble raising her arm. Patient also complained of an overall sense of not feeling well (shakes and mild fever) the day after receiving the vaccines.
No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 03-DEC-2014. The patient received two FLUMIST Quadrivalent in two days which started on 04-DEC-2014. The outcome of the event of patient received two FLUMIST Quadrivalent in two days is unknown. The report was considered to be non-serious. Corrected report on 17-DEC-2014. Coding of the event was changed. Narrative was updated.
Low grade fever, chills, lightheaded,  24 hours. On day 14 awakened with vertigo, nausea, tingling sensations on right face around eye, cheek, ear and head, pain in right side head, neck, trapezius muscle,shoulder blade, right arm, numbness in right hand, right foot.
Wrong formulation of vaccine given.  Staff thought she grabbed the single dose vial of Pfizer for 12 year old and over, but had actually grabbed Pfizer vaccine for 6month to 4 year old.  Vaccine was given undiluted.  Patient notified of error pt c/o headache and arm pain.  Pt and daughter also advised they could go to the ER if needed.
pt recv vax & that evening pt became fussy;the next morning pt devel raspy voice & barking cough;pt was seen by MD 4 days post vax & a dx of laryngeal edema was made;
Reaction started 45 minutes after Tdap given.  Started itching and scratching, broke out in hives, worse on legs and buttocks.  Took Benadryl and cool shower.  Had sore throat but went away stayed home from school 8-25-09.  Returned to school 8-26-09.  Better but still itching some.
After I got home from work, around 7 pm I started to feel side effects such as the following: fatigue, muscle aches, feverish, malaise, injection site soreness/pain. This lasted for about 48 hours.
On 11-8-13 in A.M. swelling occurred from (L) shoulder to elbow. Redness with heat TYLENOL given, Friday evening swelling receding. Sat. 11/9 evening developed hives. BENADRYL given. 11/10 Sun. A.M. facial puffiness hives on back. 2% Hydrocortisone cream applied. 11/10 Sun. P.M. hives over entire back. BENADRYL given with effect. Mon 11/11 continued with splotchiness 2% Hydrocortisone applied. Tues 11/12 pt. not complaining of hives or itchiness.
Pt developed itchiness at site of injection approx 3hrs after vaccination. The following day (10/16/19) redness and swelling developed and itching continued. 2 days post vaccination, large red area developed around injection site ad swelling and itchiness continued. On 10/22/19, pt reports that itchiness and swelling has resolved. Redness still exists at site of where band aid was placed over injection site.
This patient complained of swelling, dizziness, and subjective fever per mother. The patient went to the hospital and was admitted .
Pt c/o chest pain and fever 10 days post-vaccination. EKG - anterior fascicular block (no old EKG for comparison. Hospitalized on ward in ship, enzymes remained normal throughout course of treatment. Treated with Motrin for presumed pericarditis. Pain resolved over 4 days, remained afebrile. PE - diffuse, multiformed papular rash, non-pruritic over trunk.  8/18/08 Email received with case summary included.  Pt presented with chest pain 12 days s/p smallpox vax. Earlier he had developed an erythema multiforme reaction several days after the vax. 12/8/08 Additional MR received. Pt presented 5/9/08 with c/o substernal chest pressure and pain, dyspnea on exertion and erythma multiform rash. ST elevations noted on EKG. PE (+) for T= 100.3'F. DX:  Pericarditis. Chest pain resolved w/in 24 hrs.  F/U 6/18/08 with c/o increasing fatigue and SOB with exertion. Unable to complete daily exercises as before. Chest soreness follwing exercise. PE (+) for raspy airway sounds, otherwise WNL. Feeling tired and poorly. Polycythemia noted 7/14/08.
pt recvd vax; 2 hrs later exp profuse sweating, fever, chills & severe aches; tx w/ apap; resolved;
This spontaneous report was received from an unknown reporter regarding a 24 year old female patient. No medical history was reported. On an unknown date 2 years ago in 2011, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported0, subdermally. No concomitant medications were reported. The patient experienced did not get second or third dose after getting the first one 2 years ago. The patient was referred to her physician. Additional information has been requested.
Admission for loop ileostomy takedown. During his hospitalization he remained afebrile and hemodynamically stable. His diet was advanced and bowel function returned. Medical issues addressed during his hospitalization included wound infection which was treated with IV antibioitics. He will be sent home with oral antibiotics. Hospital admission within 6 weeks of receiving the COVID vaccine.
patient developed red rash around injection site that was hot to touch the day after injection then progressed to a small blister 2 days after injection
Blood pressure went up; Rapid heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure went up"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heart beat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
I did not have an adverse reaction to the vaccine. I started feeling symptoms on 09/06/2022 of really bad sore throat, achy, slightly nauseated and shortness of breath. I tested positive with a home test for COVID-19 on 09/08/2022. I contacted my doctor and got the prescription for PAXLOVID. As of today, I still have tiredness, shortness of breath and need small naps during the day.
Two days after I got the shot, I woke up with a mild headache, which continued for several days.  Then, this vaccine was halted.  I have continued to have a mild headache for 12 days in a row.  The pain is mild, (a 1 or 2 on a scale of 0-10)  I have had 3 days of a 1degree fever.  The pain is very mild, but concerning.
low blood pressure 85/52 pulse 102 continued to be low in the 80/55 the 1st day, 2nd day was 81/59 to 96/62 finally normal on the 12th.  also, flared up asthma.
This is in follow-up to report (s) previously submitted on 9/24/2007. Information has been received from a licensed practical nurse concerning a female (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/04161U) instead of Varivax (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  The nurse reported in follow-up that the packaging for the ZOSTAVAX (Oka/Merck) and varicella virus vaccine live (MSD) was similar and the 2 vaccines were stored in the same freezer. The varicella virus vaccine live (MSD) had run out and the ZOSTAVAX (Oka/Merck) was picked up mistakenly. The nurse hoped to avoid this event in the future. There have been positive results noted from the parents of the vaccinated child. This is one of several reports received from the same source.  Additional information is not expected.
Vaccinations given at 13:00 on 02/13/2002. Child fussy with loose stools and spitting up after vaccinations given. Tonic-clonic movements starting in left leg and spreading to left arm, then becoming generalized duration of 20 mins. Stopped with 1mg iv ativan. Temp after seizure ~102 deg. F.
Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated at physician office for a onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
LARGE AREA OF SWELLING, REDNESS, FEVERISH AT INJECTION SITE, MALAISE, BODY ACHES, WEAKNESS, FEVER IN EVENING AFTER INJECTION.
Itching all over body is still occurring and it has been 3 weeks; This is a spontaneous report from a consumer or other non-health care professional. A 59-years-old female patient started to receive BNT162b2 (BNT162B2), via an unspecified route of administration from 14Jan2021 15:45 to 14Jan2021 15:45 at single dose for covid-19 immunisation. Medical history included asthma, crohn's disease (Crohn's disease has been in remission 13 years), food allergy and known allergies (dairy, seasonal allergy, dust allergy, allergy to animal) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine (FLUOXETINE), fluticasone propionate, salmeterol xinafoate (ADVAIR), progesterone (PROGESTERONE) and estradiol (ESTRADIOL). On 14Jan2021, the patient experienced itching all over body is still occurring and it has been 3 weeks. The action taken in response to the event for BNT162b2 was not applicable. Therapeutic measures were taken as a result of itching all over body is still occurring and it has been 3 weeks (pruritus). The outcome of event was not recovered.
Patient presented to clinic for 1st dose of >12 years old Pfizer, but received Pfizer for age group 5-11 years old. Per EUA guidelines patient will receive >12 year old dose in 3 weeks as her 2nd dose.