chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 3 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
pt recvd vax for prophylaxis & exp redness & swelling at inject site; subsided
pt recv vax on 8PAR96 & returned to clinic 11APR96 to have site looked at site on lower rt arm swollen,red,hot to touch;size about 3 inches across & 3 inches down;
pt. vax'd w/ 1st & 2nd doses of hepatitis B vaccine & p/ each inj.developed rash,fever,malaise,arthralgia,& photosensitivity. Symptons worsened after 2nd dose.
Within less than three hours of injection.  Every arthritic joint (From previous injury or strains) was alternating between aching and numbing.  Took Tylenol as advise, but the aching persisted.
10/27 Vaccination given (L) deltoid approximately 5 PM. At 7 PM employee reported "shortness of breath, chills, low grade fever felt very ill all throughout night. Noted red raised diffuse rash on trunk, back did not seek medical care. Saw PMD 10/29.
pt recvd vax 28AUG93 & exp difficulty breathing & c/o throat closing; dx w/anaphylaxis & was treated w/Epi; No further details were provided;
large site rxn 7.5x9cm red, raised area;extremely pruritic, indurated;
Patient was administered Pneumo 23 as an error.  She was suppose to receive HPV vaccine.  Multiple attempts have been made to contact patient, unable to reach.  A letter has been sent out to her.  No known reaction.
Patient presented with shortness of breath and left leg pain on 9/11/11. He was diagnosed with a saddle PE and left leg DVT. Treated with BID Lovenox (1mg/kg/dose). His Moderna Bivalent vaccine was administered on 9/9/22
Heart was beating fast, my tongue felt thick and left side of neck was hurting and the next day it was swollen and very painful.
Pt, a 14 y.o came in for her first covid vaccination along with her 11 y.o. sister.  Pt should have received the adult dose of the Pfizer vaccine but instead received the pediatric Pfizer vaccine. The father was notified immediately upon discovery. Pfizer was called to determine if the series needs to be restarted. The series does not need to be restarted but we must ensure that she receives the proper dose/vaccine for the 2nd in the series
Extreme fatigue; Kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue extreme in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles on back at age of 15, very unusual but vividly remember the pain and not had it since) and pain. Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (Received first dose on an unknown date, for tolerance refer case US2022AMR094989).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue extreme and feeling abnormal. On an unknown date, the outcome of the fatigue extreme was recovered/resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fatigue extreme and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated that he/she had received the 2nd shingles shot recently. It kicked patient's butt and patient experienced extreme fatigue for a day or 2. The patient stated that he or she would still rather have the shingles shot than experiencing shingles again. Additional supportive information: No follow-up was possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094989:same report, 1st dose
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)
Within 11 days post vax the pt developed a fever and a non-pruritic rash from the face down.
?COVID arm? ? red, itchy lesion around the injection site, about 3? in diameter
This spontaneous report was received from a healthcare worker regarding a 1  year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. Concomitant medications were not reported. On 08-OCT-2015, the patient who was less than 2  years of age was vaccinated with PNEUMOVAX23 (lot #L003227; expiry date 13-OCT-2015), 0.5 ml, intramuscular in the left thigh instead of PREVNAR13. No adverse effects reported. The healthcare worker stated that it was staff error only. Product quality complaint was not filed. Additional information has been requested.
On 06/02/2021 my father started having extreme abdominal pain. He visited er and was sent home with a surgeon follow up in one week. They said he had a hernia However no hernia was noted on autopsy report. He died suddenly on the morning of 6/9/2021 just before surgeon appointment
This spontaneous report was received from a medical assistant refers to a patient of unknown age (gender unspecified). On 30-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number 1193AA, route not reported), which had expired on 25-OCT-2012. No concomitant medications were reported. There was no adverse event report. It was, unspecified if patient sought medical attention. Additional information has been requested.
lump becoming bigger everyday/hard lump on the injection site; hot to touch lump; large, reddish, hard lump on the injection site; painful lump; pain scale of 5; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site), VACCINATION SITE WARMTH (hot to touch lump), VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site), VACCINATION SITE WARMTH (hot to touch lump), VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5). The patient was treated with IBUPROFEN for Adverse event, at a dose of Every 4 hours and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 tablets Tylenol cold compress. At the time of the report, VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site) and VACCINATION SITE WARMTH (hot to touch lump) had not resolved and VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5) outcome was unknown.            The pain scale is 5 even if she took pain relievers every 4 hours.  The patient took 2 tablets of Ibuprofen every 4 hours alternate with 2 tablets of Tylenol and applied cold compress.   This case was linked to MOD-2021-272055 (Patient Link).
Information has been received from a registered nurse referring to an 14 year old patient of unknown gender. On 07-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L014415, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pinkeye; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 02Feb2021 (Lot number: EL9261, Expiry date: 12May2021), at 82 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history included pacemaker user from an unknown date and ongoing. Concomitant medications included amlodipine, pantoprazole, atorvastatin, "Dxazepan" (as provided by the reporter) and "Qap" (as provided by the reporter) all taken for unknown indications, start and stop dates not reported. On 22Feb2021, the patient had a pinkeye. The patient was scheduled to get the second dose on 23Feb2021. The reporter asked if it was okay to get the second dose and if there would by complications. Treatment for the event included an unspecified eyedrops. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Systemic: pupils got dilated and pt stated he couldn't see. BP runs low and skin got pale-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: by the time when 911 arrived, his skin came back normal and reported that he was able to see. He was concious whole time. this happened for about 20 min until he got back to normal status.
Moderate fatigue; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, FATIGUE (Moderate fatigue), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.    This case was linked to MOD-2021-317946 (Patient Link).
Pt recvd 3 doses of Engerix-B 6NOV90, 4DEC90, & 30APR91 & 7SEP91 it was determined that pts titer was negative p/3 doses of Engerix-B;
Fever, rigor, diarrhea, myalgias, lymphadenopathy.
Information has been received from a registered nurse referring to unspecified number of patients of unknown ages and genders. The reporter reported that improperly stored RECOMBIVAX HB injection (Lot#, strength, dose, frequency and route were unspecified) was given to unspecified number of patients since 24-NOV-2014. No adverse effect was reported. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  immediately after 1st IM dose pt experienced itching at injection site, itching resolved with 10 minutes
The pt vomited several hours after receiving a hepatitis A vaccine given at another health care providers office. No further information is available.
Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: El183), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (other vaccine same date product=Pfizer,, other vaccine same date lot number=Ek5730,, other vaccine same date dose number=1,, other vaccine same date vaccine location=Left arm,), for COVID-19 immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine".  The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious), outcome "recovering" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.
Respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Severe and Moderate).   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection) was resolving.            Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that  reporter's causality for the event of respiratory infection with humira(adalimumab) was no reasonable possibility. Treatment information was not provided.
Chills; Bone and muscle pain; Bone and muscle pain; Headache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13May2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 14May2021 at 02:00, the patient experienced chills, bone and muscle pain, headache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent bioiq test via nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, bone and muscle pain, headache and stomach ache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I only had a sore throat and fatigue. I went to the urgent care and they tested me for COVID-19 and it came back positive. They prescribed me BROMFED and another medication.
Information has been received from a physician and with a follow up telephone call concerning a 17 year old female patient with no pertinent medical history who on 16-APR-2008 at 11:30 AM was vaccinated with a first dose of GARDASIL (lot # 659657/1487U) and with a dose of MENACTRA. Concomitant suspect therapy included amoxicillin (dose, duration not indicated) for sinus infection. The physician reported that "patient received her first injection on 16-APR-2008 and left the doctor's office fine. She picked up a prescription for amoxicillin and took it with a bowl of taco soup. Within two hours after she received GARDASIL and MENACTRA at 01:30 PM she had tongue swelling, vomiting and trouble breathing. The ambulance came and the patient went to the emergency room where she was treated with steroid injections. The patient was not admitted to the hospital. She left the emergency room recovered and was placed on oral steroids. The emergency room physician felt amoxicillin was the cause of the anaphylactic shock. The reporting physician was not sure of cause of the anaphylactic shock was either from MENATRA, amoxicillin or GARDASIL. The reporting physician considered anaphylactic shock to be disabling and life threatening. Additional information has been requested.
Took unrefrigerated course of Vivotif; Spontaneous report received on 31DEC2019.  A pharmacist reported that a male consumer "took unrefrigerated course of Vivotif" (PT: Product storage error). The consumer took Vivotif (lot number: 3003306) for immunisation. On 24DEC2019, the consumer picked up Vivotif. On 25DEC2019, the consumer started Vivotif and completed the Vivotif course but never refrigerated it. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif which were never refrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable.; Sender's Comments: A consumer took all four doses of Vivotif which were never refrigerated (Incorrect product storage). Considering the nature of the event, the causality of the event is assessed as not applicable.
Pt reported developing "welts" (6 hours after receiving flu vax) on lower forearm of same arm vax was administered.  3-4" area of reddened welts.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001854 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fifth out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked to cases no. US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001855, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
This spontaneous report as received from a healthcare worker refers to a 37 year old male patient with back pain, no drug reactions and no concomitant medication. On an unknown dates, the patient was vaccinated with two doses of M-M-R II dose, route of administration, lot number and expiration date unknown. On 27-MAY-2015, the patient sought medical attention for an unspecified reason at the office of healthcare worker. The result of a mumps titer obtained on 27-MAY-2015 was Antibody (AB) Immunoglobulin G (IGG): 1,04: low. Healthcare worker additionally stated the patient's results were a negative titer for mumps. The outcome of the event was not reported. The relatedness between the event and the therapy with M-M-R II was not reported. Additional information has been requested.
Vaccinated 1/6, on 1/14 started with a fever-103 and on and off over the weekend, slight runny nose and cough. Sunday afternoon noticed a slight rash-on 1/14 move on face and trunk and then spread to back of arms-fever broke evening on 1/19.