chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 17:15 (Lot number: EP7534) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medication(s) included: CELECOXIB. Vaccination history included: Bnt162b2 (First dose, Lot Number: EN6198, administration time: 05:15 PM, vaccine location: right arm), administration date: 27Feb2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 04Apr2021 21:00, outcome "not recovered", described as "Tingling in hands and feet". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Given Pfizer bivalent 0.3 ml adult booster dose Intended dose, Pfizer Bivalent 0.2 ml booster dose
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (unspecified if ongoing); "Penicilin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: Tested positive again after 4 days from 2nd negative test; (20Apr2023) Positive, notes: Tested positive again after 4 days from 2nd negative test; (Apr2023) Negative, notes: Tested positive again after 4 days from 2nd negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: COVID 19 Treatment brand: Pfizer from 09Apr2023 to 13Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an LPN concerning a 12 year old female with no pertinent medical history and no history of drug reactions/allergies, who on 04-JUN-2007 was vaccinated intramuscularly in the arm with Gardasil (lot # 657736/0389U). There was no concomitant medication. on 04-JUN-2007, following vaccination, the patient developed a rash over her whole body. The rash was red and itchy and was described as developing into hives from the head to toe. The rash started over the whole body a few hours after vaccination. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from an LPN and the patient's medical records concerning a 12 year old female with no pertinent medical history and no history of drug reactions/allergies, who on 04-JUN-2007 at 3:30 PM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (0.5 ml) (lot # 657736/0389U). There was no illnesses at time of vaccination. Concomitant therapy included amoxicillin, loratadine and ASTELIN (condition unspecified). Previous vaccination included varicella vaccine on 15-JUN-2006 (manufacturer unknown). The patient presented to her physician's office on 06-JUN-2006 with a scattered erythematous round macular rash with some target lesions on her chest, face, arms, back and upper legs. The rash started on 04-JUN-2007, and was persistent and worsened over 48 hours with itching. The patient denied exposure to change in food, detergent, and antibiotics. The patient also denied fever. A review of eyes, ENMT, and lymph were within normal limits. A urinalysis revealed blood, however it was reported that the patient had her menses. The patient was assessed for dermatitis due to drugs and medicine and placed on a course of prednisone. On 30-JUN-2007, the patient was again seen by her physician for follow-up of rash that was temporal associated with GARDASIL. At that time the rash had resolved, however there were traces of lighter colored skin where the lesions were on her arms and neck. The patient denied fatigue and  weight change. The patient was advised to wear sunblock to prevent burning and worsening scarring and was informed that the residual rash would fade over time. The patient was assessed for GARDASIL allergy. The patient subsequently recovered from the erythematous macular rash on 30-JUN-2007. It was planned to not complete the series of GARDASIL. No further information is expected.
I received flu shot at 8:30 a.m. 11-16-18 by 2 pm on the same day I had a bad headache which lasted for 2 days. My arm ached around and at the site of injection and throbbed. I did put heat and alternated with ice and the heat seemed to help but this lasted for approx. 18 hours. On Sunday 11-18-18 I experienced stomach cramps and loose stools. Which lasted for approx. 6 hours.  I am a healthy person otherwise and was feeling well before the injection.
A day post my 3rd vaccine, my lymph nodes began swelling  and my left breast is still swollen as well and hives in mid to low back left of the spine. Very sensitive to touch and causes left side pain and soreness.  Lymph node swelling has currently started to come down, however there is still some swelling present in my shoulder and breast. Fatigue has been present and my taste has seemed to be off as well.  Physician told me to rest for 2-3 weeks.
I had a headache  within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache,  body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9.  Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
Patient had the adverse reaction of hives/rash on his chest, stomach. His symptoms started the day after he received the vaccination (6/30). Patient was instructed to try Zyrtec or Benadryl (mom given correcting dosing). Patient's mom will call the office back with any worsening symptoms and the ED with any difficulty breathing, facial swelling, etc.
15 MINUTES AFTER VACCINE, PATIENT'S MOM REPORTED BUMPS APPEARED ON PATIENTS ARM. PATIENT WAITED 15 MORE MINUTES AND THERE WAS NO CHANGE. WHEN ASKED, PATIENT STATED THERE WAS NO DIZZINESS, NO NAUSEA, NO SHORTNESS OF BREATH, NO PAIN, NO ITCHING, NO OTHER SIDE EFFECTS.  PATIENT WAS REFFERED TO FOLLOW UP WITH PEDIATRICIAN.
patient received a 0.5 ml dose of vaccine instead of 0.3 ml resulting in high fever chills headache
Mild to moderate injection site soreness 48 hours; This is a spontaneous report from a non-contactable other hcp. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 30Dec2020 19:30 at single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication included amitriptyline (AMITRIPTYLINE), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced mild to moderate injection site soreness for 48 hours (non-serious) on 30Dec2020 20:00 with outcome of recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient hospitalized within 6 weeks for receiving COVID vaccination. Hospitalized on 3/16/21 for 3 days, and 3/26/21 for 4 days.
A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis; A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis; This non-serious spontaneous safety report, Case ID: 02302242/Interaction Number 02302233, was received by partner, on 13DEC2022 and forwarded on 14DEC2022 from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis".  Further information is expected.
Chest tightness as if you had a person on top, shortness of breath, cardiac arrhythmia.
8/25 reported warmth, redness, pain from shoulder to elbow - ice pack.
Redness, swelling, erythema at site. Aches, fever. 2 and 3 days after injection.
This spontaneous report was received from an office manager and refers to an unknown number of adult patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the adult patients had received two doses of pediatric RECOMBIVAX HB (doses, route of administration, anatomical location, lot# and expiration date were not provided) to equal adult doses. No adverse effects reported. Product quality complaint was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001190.
patient recieved a Twinrix expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number 93KF5, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 28th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: The pharmacist reported that patient received a Twinrix expired dose by error. The reporter consented to follow up by email. Additional Supportive Information: On 28th March 2022, The patient received dose of Twinrix that was already got expired on 22nd February 2022, which led to expired vaccine used.
Shortness of breath and chest pain 2 days after vaccine. Pain on the upper left side of chest and constant shortness of breath. Not fixed upon leaving the hospital.
Pentacel was given 5/12/23 that was noted to have expired on 5/4/23 with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 12-May-2023 that was noted to have expired on 04-Apr-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-May-2023, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE for Suspension for injection (dosage, frequency, strength, lot number: not reported and expiry date: 04-Apr-2023) via unknown route in unknown administration site for immunization. Information on the batch number was requested and on the same day Pentacel was given, that was noted to have expired with no reported adverse event (expired product administered).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received HAVRIX 1440 adult. Concomitant products included Aspirin, Calcium Unknown and vitamin D. On 23rd April 2018, the patient received HAVRIX 1440 adult (intramuscular). In April 2018, less than a week after receiving HAVRIX 1440 adult, the patient experienced injection site erythema, injection site swelling and injection site scab. On 17th May 2018, the patient experienced injection site itching and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and injection site lump were not recovered/not resolved and the outcome of the injection site scab was recovered/resolved. The reporter considered the injection site erythema, injection site swelling, injection site scab, injection site itching and injection site lump to be related to HAVRIX 1440 adult. Additional details were provided as follows: The patient's concomitant medication included Insulin as well. The patient experienced redness, swelling and scabbing at the injection site within the first week after the vaccination. It presented within that week and resolved within that week. The scabbing was described as 2 or 3 long marks like little claw marks. On the day before reporting, 24 days after vaccination, she noticed a quarter size areas at the injection site that was red, slightly swollen and itchy. There was also a lump at injection site.
Pt presents to the clinic approximately 5 hours post vaccination with complaint of chest pain. Pt rated pain at a 5 on a 0-10 scale. Diagnostic studies and treatment in progress now.
Three weeks after first dose, vertigo, dizziness, ear pain, eye pain.   I?m under an ENT Drs care.   I?m still having vertigo.   It?s been 10 weeks since onset of symptoms.
Patient immunization on 5Nov07. Band-aid came that night and parent noticed small red area. Patient came to Hospital for check-up of site. on 8Nov07. 3.5 cm across and 5.0 cm vertical. red/warm area to right upper arm.
Information has been received from a healthcare student referring to a 53 year old patient of unknown gender. Information regarding the medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with first dose of (Oka/Merck) ZOSTAVAX (dose, strength, lot # and route were not reported). ON 20-JUL-2015 the patient was vaccinated with the second dose of (Oka/Merck) ZOSTAVAX (dose, strength and route were not reported, lot # L006382 expiry date: 25-MAY-2016) (extra dose administered). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Died 5/11/2021 Causes of death listed on death certificate: 1) covid  2) chronic lymphocytic leukemia
On Nov 24 Negative to the doctor in Bayamón because I had a headache, fever, chills, and was very weak. I took a test for COVID-19 and it came out Negative. They did blood tests and they told me that I had low platelets and they gave me 6 injections and prescribed Acetaminophen pills for the headache that wouldn't go away. Then 3 days later I went back to the doctor and it turned out that the platelets had dropped even more and they took me to an ER and treated him. I was hospitalized for 3 days. and improve. At 2-3 weeks I had a sore throat, a little fever, a cough, a bit of a cold. I did a home test and it came out negative.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 12:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 12:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 94.93.  No concomitant medications were reported.  Batch number 019B21A administered on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
10/30/22 presents to EC ED for "nausea and vomiting". PMHx of "asthma, diabetes,htn"
Swelling between the last joint and the finger nail, hard and painless; Blistering on toes and blistered fingure; Large rash; Fever; Very swollen and painful lymph node in the armpit of injection arm; Sore arm; Swollen arm; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Malaise), SWELLING (Swelling between the last joint and the finger nail, hard and painless) and BLISTER (Blistering on toes and blistered fingure) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Malaise), PYREXIA (Fever) and LYMPHADENOPATHY (Very swollen and painful lymph node in the armpit of injection arm). On an unknown date, the patient experienced SWELLING (Swelling between the last joint and the finger nail, hard and painless), BLISTER (Blistering on toes and blistered fingure) and RASH (Large rash). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Malaise), PYREXIA (Fever) and LYMPHADENOPATHY (Very swollen and painful lymph node in the armpit of injection arm) had resolved and SWELLING (Swelling between the last joint and the finger nail, hard and painless), BLISTER (Blistering on toes and blistered fingure) and RASH (Large rash) outcome was unknown.            Concomitant medications were not provided. Treatment information included over the counter cortisone. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-020191 (Patient Link).
Sore arm starting around 3:00, an hour or so after shot; then starting around 11:00pm day of shot, fever (101.5), chills, headache, arm pain, over by noon the next day; red rash (about 4 in. in diameter) and swelling of arm started the morning after the shot; arm still has red rash (about 5 in. in diameter) and soreness today, 3 days after shot.
I contracted COVID 19 October 19, 2021. I was extremely fatigued for 8 days, with brain fog, fever, chills, body aches, headache, congestion. I needed the Regeneron Antibodies injection.